Biofind http://www.biofind.com/ info@biofind.com Biofind http://www.biofind.com/ info@biofind.com Biofind.com feeds http://www.biofind.com/Events Generated by Atom.NET Copyright © Biofind.com Events feed 2008-10-21T10:49:25+01:00 Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=448 2008-09-30T19:59:32+01:00 2008-09-30T19:59:32+01:00 2008-09-30T19:59:32+01:00

Optimizing the Scientific Continuum from the Discovery-Development Handoff to Phase III IBC�??s 5th Annual Early to Late Stage Bioprocess Development Summit offers strategies for your analytical and process development programs that optimize the use of internal and external resources and accelerate the development timeline. The meeting is ideally suited for both early stage companies working toward clinical development and for members of cross-functional project teams in larger organizations aiming to streamline and platform development functions.

Optimizing the Scientific Continuum from the Discovery-Development Handoff to Phase III IBC�??s 5th Annual Early to Late Stage Bioprocess Development Summit offers strategies for your analytical and process development programs that optimize the use of internal and external resources and accelerate the development timeline. The meeting is ideally suited for both early stage companies working toward clinical development and for members of cross-functional project teams in larger organizations aiming to streamline and platform development functions. Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=447 2008-09-30T19:57:56+01:00 2008-09-30T19:57:56+01:00 2008-09-30T19:57:56+01:00

Drawing upon the 15th Annual Chips to Hits®, 7th Annual Biomarkers, and 7th annual Molecular Diagnostics meetings, IBC developed the Discovery2Diagnostics Conference & Exhibition to reflect recent changes in these industries and to capture opportunities presented by the fast-paced developments in technologies and research throughout the discovery to diagnostics spectrum. The scope of this meeting includes more RNAi related research and development as it effects sequencing and detection technologies, biomarkers and molecular diagnostics, recent work to deliver point-of-care (or near POC) molecular diagnostics and sessions with panel discussions on related regulatory and reimbursement issues. The challenges experienced by those involved in the Discovery2Diagnostics spectrum and the enabling breakthroughs that bridge the gap between biomarkers and molecular diagnostics in the R&D setting and the clinic will also be explored.

Drawing upon the 15th Annual Chips to Hits®, 7th Annual Biomarkers, and 7th annual Molecular Diagnostics meetings, IBC developed the Discovery2Diagnostics Conference & Exhibition to reflect recent changes in these industries and to capture opportunities presented by the fast-paced developments in technologies and research throughout the discovery to diagnostics spectrum. The scope of this meeting includes more RNAi related research and development as it effects sequencing and detection technologies, biomarkers and molecular diagnostics, recent work to deliver point-of-care (or near POC) molecular diagnostics and sessions with panel discussions on related regulatory and reimbursement issues. The challenges experienced by those involved in the Discovery2Diagnostics spectrum and the enabling breakthroughs that bridge the gap between biomarkers and molecular diagnostics in the R&D setting and the clinic will also be explored. Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=444 2008-09-29T10:45:59+01:00 2008-09-29T10:45:59+01:00 2008-09-29T10:45:59+01:00

This two-day conference will explore the skills, processes, and tools necessary to achieve project management success at your organisation. Leaders in their fields will present topnotch lectures and facilitate lively discussions on how they have been successful in their organisation and where they have observed successful leadership in other settings. And don�??t forget your business cards, because this conference will provide extensive networking opportunities to help you grow your network of project management colleagues from whom you can learn for a lifetime. For more information visit: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=17005&eventType=Meeting

This two-day conference will explore the skills, processes, and tools necessary to achieve project management success at your organisation. Leaders in their fields will present topnotch lectures and facilitate lively discussions on how they have been successful in their organisation and where they have observed successful leadership in other settings. And don�??t forget your business cards, because this conference will provide extensive networking opportunities to help you grow your network of project management colleagues from whom you can learn for a lifetime. For more information visit: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=17005&eventType=Meeting Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=433 2008-08-26T00:27:33+01:00 2008-08-26T00:27:33+01:00 2008-08-26T00:27:33+01:00

This workshop, in collaboration with Ivy Tech Community College, begins by discussing in detail the FDA organization structure and the cGMP regulations. It provides a broad overview of cGMP compliance ranging from the FDA�??s cGMP regulations through other FDA documents and industry best practices. The course also provides up-to-date regulatory information from other regulatory authorities.

This workshop, in collaboration with Ivy Tech Community College, begins by discussing in detail the FDA organization structure and the cGMP regulations. It provides a broad overview of cGMP compliance ranging from the FDA�??s cGMP regulations through other FDA documents and industry best practices. The course also provides up-to-date regulatory information from other regulatory authorities. Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=522 2008-10-20T10:53:36+01:00 2008-10-20T10:53:36+01:00 2008-10-20T10:53:36+01:00

This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. Description This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics. Areas Covered in the seminar: * Overview of the Clinical Trials Process, Phase I-IV studies including principles of working in a regulated environment; discuss FDA regulation, good clinical practice (GCP), and ICH Guidelines and Overview of IND/IDE process. * Ethics of clinical trials including historical background, current issues and current Regulatory observations. * Essential study documents that are required before trial initiation, during trial conduct and study close-out. Who will benefit: This webinar will provide valuable assistance to all personal in: * Pharmaceutical * Biotechnology * CROs Instructor Profile: Elizabeth Bergan, joined PQC Consulting, Inc., as a Senior Consultant. She has over 10 years of clinical research experience in the pharmaceutical and medical device industry. She recently held the position of Managing Partner for Eye Trials, a contract research organization overseeing a number of multi-center clinical trials. Prior to that, she had held various management positions at STAAR Surgical including Manager of Clinical Affairs. Her clinical studies experience includes protocol design, trial site initiation, study close-out, final data collection and submission of Pre-Market Application (PMA). At STAAR Surgical, Elizabeth managed several large multi-center clinical trials and was instrumental in preparing clinical trial data for an FDA Advisory Panel meeting. Consequently, her team was successful in obtaining FDA approval for STAAR Surgical Visian ICL�?�. She has extensive experience preparing for and participating in FDA Bioresearch Monitoring audits. Through her various positions, Elizabeth has been involved with the development of policies and procedures for clinical protocol and case report form design, clinical monitoring, adverse event reporting, and clinical data management. She has trained a number of employees on applicable FDA Guidelines and Good Clinical Practices (GCPs) as well as ICH Guidelines.

This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. Description This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics. Areas Covered in the seminar: * Overview of the Clinical Trials Process, Phase I-IV studies including principles of working in a regulated environment; discuss FDA regulation, good clinical practice (GCP), and ICH Guidelines and Overview of IND/IDE process. * Ethics of clinical trials including historical background, current issues and current Regulatory observations. * Essential study documents that are required before trial initiation, during trial conduct and study close-out. Who will benefit: This webinar will provide valuable assistance to all personal in: * Pharmaceutical * Biotechnology * CROs Instructor Profile: Elizabeth Bergan, joined PQC Consulting, Inc., as a Senior Consultant. She has over 10 years of clinical research experience in the pharmaceutical and medical device industry. She recently held the position of Managing Partner for Eye Trials, a contract research organization overseeing a number of multi-center clinical trials. Prior to that, she had held various management positions at STAAR Surgical including Manager of Clinical Affairs. Her clinical studies experience includes protocol design, trial site initiation, study close-out, final data collection and submission of Pre-Market Application (PMA). At STAAR Surgical, Elizabeth managed several large multi-center clinical trials and was instrumental in preparing clinical trial data for an FDA Advisory Panel meeting. Consequently, her team was successful in obtaining FDA approval for STAAR Surgical Visian ICL�?�. She has extensive experience preparing for and participating in FDA Bioresearch Monitoring audits. Through her various positions, Elizabeth has been involved with the development of policies and procedures for clinical protocol and case report form design, clinical monitoring, adverse event reporting, and clinical data management. She has trained a number of employees on applicable FDA Guidelines and Good Clinical Practices (GCPs) as well as ICH Guidelines. Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=521 2008-10-20T10:50:59+01:00 2008-10-20T10:50:59+01:00 2008-10-20T10:50:59+01:00

This webinar covers the current FDA requirement that all raw materials that are received and used in producing APIs & Drug Products should be qualified using a system to ensure that raw materials are of acceptable identity, quality purity before use. Description During the last several years, FDA has issued numerous observations and warning letters to pharmaceutical and biotechnology companies for lack of adequate systems for evaluating the suppliers of raw materials and the components, to ensure that these materials are acceptable for use. It is the FDA requirement that all raw materials that are received and used in producing APIs and Drug Products should be qualified using a system to ensure that raw materials are of acceptable identity, quality and purity before use. Areas Covered in the seminar: * Establish appropriate specifications for these materials and to assure your suppliers provide materials meeting these specifications. * Have the specifications be approved by the quality unit. * Ensure that raw materials received are suitable and approved by the quality unit prior to use. * Set a vendor qualification program that provide adequate evidence that the manufacturer can consistently provide reliable and safe materials. * Audit, monitored and regularly scrutinized the suppliers to assure ongoing reliability. * We will also review FDA 483s and Warning Letters relating to this topics. Who will benefit: * Pharmaceutical * Biotechnology industries Instructor Profile: Jamie Jamshidi, CEO/President of PQC Consulting Inc., has over 21 years of industry experience including Small Molecules and Biological/Protein products. She retired from Amgen Inc. after 17 years of service with the company. She has extensive knowledge and expertise in the areas of Quality Assurance, Manufacturing/Operations, Validations, Analytical Laboratories, Regulatory Submissions, Regulatory Inspections (PAI), Project Management, and Managing Contract Manufacturing sites, Technology Transfer, Management and Team Leadership including a broad understanding of the entire drug development process. She has extensive knowledge of FDA, EP, and JP regulations, ICH guidelines, and Qualified Person (QP) requirements under EU Directives.

This webinar covers the current FDA requirement that all raw materials that are received and used in producing APIs & Drug Products should be qualified using a system to ensure that raw materials are of acceptable identity, quality purity before use. Description During the last several years, FDA has issued numerous observations and warning letters to pharmaceutical and biotechnology companies for lack of adequate systems for evaluating the suppliers of raw materials and the components, to ensure that these materials are acceptable for use. It is the FDA requirement that all raw materials that are received and used in producing APIs and Drug Products should be qualified using a system to ensure that raw materials are of acceptable identity, quality and purity before use. Areas Covered in the seminar: * Establish appropriate specifications for these materials and to assure your suppliers provide materials meeting these specifications. * Have the specifications be approved by the quality unit. * Ensure that raw materials received are suitable and approved by the quality unit prior to use. * Set a vendor qualification program that provide adequate evidence that the manufacturer can consistently provide reliable and safe materials. * Audit, monitored and regularly scrutinized the suppliers to assure ongoing reliability. * We will also review FDA 483s and Warning Letters relating to this topics. Who will benefit: * Pharmaceutical * Biotechnology industries Instructor Profile: Jamie Jamshidi, CEO/President of PQC Consulting Inc., has over 21 years of industry experience including Small Molecules and Biological/Protein products. She retired from Amgen Inc. after 17 years of service with the company. She has extensive knowledge and expertise in the areas of Quality Assurance, Manufacturing/Operations, Validations, Analytical Laboratories, Regulatory Submissions, Regulatory Inspections (PAI), Project Management, and Managing Contract Manufacturing sites, Technology Transfer, Management and Team Leadership including a broad understanding of the entire drug development process. She has extensive knowledge of FDA, EP, and JP regulations, ICH guidelines, and Qualified Person (QP) requirements under EU Directives. Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=507 2008-10-20T10:08:01+01:00 2008-10-20T10:08:01+01:00 2008-10-20T10:08:01+01:00

This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. Description This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics. Areas Covered in the seminar: * Overview of the Clinical Trials Process, Phase I-IV studies including principles of working in a regulated environment; discuss FDA regulation, good clinical practice (GCP), and ICH Guidelines and Overview of IND/IDE process. * Ethics of clinical trials including historical background, current issues and current Regulatory observations. * Essential study documents that are required before trial initiation, during trial conduct and study close-out. Who will benefit: This webinar will provide valuable assistance to all personal in: * Pharmaceutical * Biotechnology * CROs Instructor Profile: Elizabeth Bergan, joined PQC Consulting, Inc., as a Senior Consultant. She has over 10 years of clinical research experience in the pharmaceutical and medical device industry. She recently held the position of Managing Partner for Eye Trials, a contract research organization overseeing a number of multi-center clinical trials. Prior to that, she had held various management positions at STAAR Surgical including Manager of Clinical Affairs. Her clinical studies experience includes protocol design, trial site initiation, study close-out, final data collection and submission of Pre-Market Application (PMA). At STAAR Surgical, Elizabeth managed several large multi-center clinical trials and was instrumental in preparing clinical trial data for an FDA Advisory Panel meeting. Consequently, her team was successful in obtaining FDA approval for STAAR Surgical Visian ICL�?�. She has extensive experience preparing for and participating in FDA Bioresearch Monitoring audits. Through her various positions, Elizabeth has been involved with the development of policies and procedures for clinical protocol and case report form design, clinical monitoring, adverse event reporting, and clinical data management. She has trained a number of employees on applicable FDA Guidelines and Good Clinical Practices (GCPs) as well as ICH Guidelines.

This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. Description This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics. Areas Covered in the seminar: * Overview of the Clinical Trials Process, Phase I-IV studies including principles of working in a regulated environment; discuss FDA regulation, good clinical practice (GCP), and ICH Guidelines and Overview of IND/IDE process. * Ethics of clinical trials including historical background, current issues and current Regulatory observations. * Essential study documents that are required before trial initiation, during trial conduct and study close-out. Who will benefit: This webinar will provide valuable assistance to all personal in: * Pharmaceutical * Biotechnology * CROs Instructor Profile: Elizabeth Bergan, joined PQC Consulting, Inc., as a Senior Consultant. She has over 10 years of clinical research experience in the pharmaceutical and medical device industry. She recently held the position of Managing Partner for Eye Trials, a contract research organization overseeing a number of multi-center clinical trials. Prior to that, she had held various management positions at STAAR Surgical including Manager of Clinical Affairs. Her clinical studies experience includes protocol design, trial site initiation, study close-out, final data collection and submission of Pre-Market Application (PMA). At STAAR Surgical, Elizabeth managed several large multi-center clinical trials and was instrumental in preparing clinical trial data for an FDA Advisory Panel meeting. Consequently, her team was successful in obtaining FDA approval for STAAR Surgical Visian ICL�?�. She has extensive experience preparing for and participating in FDA Bioresearch Monitoring audits. Through her various positions, Elizabeth has been involved with the development of policies and procedures for clinical protocol and case report form design, clinical monitoring, adverse event reporting, and clinical data management. She has trained a number of employees on applicable FDA Guidelines and Good Clinical Practices (GCPs) as well as ICH Guidelines. Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=333 2008-03-10T11:01:08+00:00 2008-03-10T11:01:08+00:00 2008-03-10T11:01:08+00:00

The event is the 7th annual Autumn R&D Leaders�?? Forum and will once again provide a key meeting place for top-level pharma and biotech R&D executives. The highly interactive conference agenda will focus on the discussion of solutions to core strategic challenges along the length of the pipeline and will be complemented by superb networking opportunities. The event is running in parallel with the Oncology Leaders�?? Forum 2008

The event is the 7th annual Autumn R&D Leaders�?? Forum and will once again provide a key meeting place for top-level pharma and biotech R&D executives. The highly interactive conference agenda will focus on the discussion of solutions to core strategic challenges along the length of the pipeline and will be complemented by superb networking opportunities. The event is running in parallel with the Oncology Leaders�?? Forum 2008 Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=332 2008-03-10T10:57:41+00:00 2008-03-10T10:57:41+00:00 2008-03-10T10:57:41+00:00

The Oncology Leaders�?? Forum provides an annual high-level meeting place for senior level figures driving the development, approval and launch of novel cancer therapies of all classes. The �??08 program will feature over 40 high profile speakers and a selection of highly interactive discussion and workshop sessions. Please visit the event website for the latest agenda information. The event is running in parallel with the R&D Leaders�?? Forum Autumn 2008.

The Oncology Leaders�?? Forum provides an annual high-level meeting place for senior level figures driving the development, approval and launch of novel cancer therapies of all classes. The �??08 program will feature over 40 high profile speakers and a selection of highly interactive discussion and workshop sessions. Please visit the event website for the latest agenda information. The event is running in parallel with the R&D Leaders�?? Forum Autumn 2008. Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=409 2008-07-08T21:02:53+01:00 2008-07-08T21:02:53+01:00 2008-07-08T21:02:53+01:00

This Pharma IQ conference is essential for scientists in drug discovery who wish to understand how to identify poorly soluble drugs. Avoiding unnecessary formulation development costs, accelerating timelines, expanding pipelines, establishing effective research investments, and incorporating the correct strategy are all vital for scientists to produce and develop bioavailable drugs. This conference, now back in the U.S., will provide the necessary updates, cutting edge science, strategies, and technologies incorporated by other companies that will enable you to find out what best practice is for you! Topics of discussion include: �?� Actively seek new and improved ways to understand the importance of solubility in exposure during preclinical and clinical phases, and what parameters to control �?� Avoid overcomplicating preclinical and clinical exposure issues �?� Identifying compounds that will have issues during preclinical and clinical phases, and what you can do �?� Build a higher probability of a new drug passing through the development pipeline �?� Build an effective research strategy for the unique properties of a molecule �?� Improve efficiency and throughput in testing compounds and develop good strategies to deal with this in formulation

This Pharma IQ conference is essential for scientists in drug discovery who wish to understand how to identify poorly soluble drugs. Avoiding unnecessary formulation development costs, accelerating timelines, expanding pipelines, establishing effective research investments, and incorporating the correct strategy are all vital for scientists to produce and develop bioavailable drugs. This conference, now back in the U.S., will provide the necessary updates, cutting edge science, strategies, and technologies incorporated by other companies that will enable you to find out what best practice is for you! Topics of discussion include: �?� Actively seek new and improved ways to understand the importance of solubility in exposure during preclinical and clinical phases, and what parameters to control �?� Avoid overcomplicating preclinical and clinical exposure issues �?� Identifying compounds that will have issues during preclinical and clinical phases, and what you can do �?� Build a higher probability of a new drug passing through the development pipeline �?� Build an effective research strategy for the unique properties of a molecule �?� Improve efficiency and throughput in testing compounds and develop good strategies to deal with this in formulation Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=404 2008-07-07T21:36:58+01:00 2008-07-07T21:36:58+01:00 2008-07-07T21:36:58+01:00

Learn about methods of investigating the root and probable cause of deviations that occur in pharmaceutical and biopharmaceutical manufacturing, and hear case studies of actual investigations. Please visit www.IBCLifeSciences.com/courses for complete course agendas and the dates and locations for the more than 80 separate courses to be presented in the fall 2008 and spring 2009 terms.

Learn about methods of investigating the root and probable cause of deviations that occur in pharmaceutical and biopharmaceutical manufacturing, and hear case studies of actual investigations. Please visit www.IBCLifeSciences.com/courses for complete course agendas and the dates and locations for the more than 80 separate courses to be presented in the fall 2008 and spring 2009 terms. Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=484 2008-10-06T11:52:32+01:00 2008-10-06T11:52:32+01:00 2008-10-06T11:52:32+01:00

Reasons to register today: �?� Summarise methods to make informed decisions about conducting clinical studies from a biopharmaceutical perspective �?� Identify the data management, CMC supply chain, operational requirements and CRO infrastructure in India and China �?� Discuss the regulatory requirements and implication of conducting these studies in India and China �?� Explain government regulation and legal infrastructure in India and China �?� Discover how to improve your supplier-client relationships �?� Complete trials on schedule and budget by learning to overcome hurdles in investigator/patient recruitment �?� What are the issues with off-shoring trials to countries such as China, India and Latin America, and ways to overcome them? �?� Explore innovative strategies for outsourcing, what you should be looking for in a CRO? �?� What considerations are involved in writing and managing a sensible contract? �?� How can you take advantage of the global market for clinical trials?

Reasons to register today: �?� Summarise methods to make informed decisions about conducting clinical studies from a biopharmaceutical perspective �?� Identify the data management, CMC supply chain, operational requirements and CRO infrastructure in India and China �?� Discuss the regulatory requirements and implication of conducting these studies in India and China �?� Explain government regulation and legal infrastructure in India and China �?� Discover how to improve your supplier-client relationships �?� Complete trials on schedule and budget by learning to overcome hurdles in investigator/patient recruitment �?� What are the issues with off-shoring trials to countries such as China, India and Latin America, and ways to overcome them? �?� Explore innovative strategies for outsourcing, what you should be looking for in a CRO? �?� What considerations are involved in writing and managing a sensible contract? �?� How can you take advantage of the global market for clinical trials? Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=370 2008-06-04T14:35:18+01:00 2008-06-04T14:35:18+01:00 2008-06-04T14:35:18+01:00

CHI�??s Sixth Annual RNAi for Screening: How to Best Utilize RNAi as a Screening Tool CHI�??s Second Annual RNAi for Therapeutics: How to Best Transition From the Lab to the Clinic CHI�??s Second Annual Kinase Inhibitors: Moving Forward into Clinical Studies CHI�??s Third Annual Ion Channels as Therapeutic Targets A Flood of Potential for Drug Discovery CHI�??s Second Annual HDAC Inhibitors: Targeting Oncology and Beyond Developing Candidates for Targeted Therapies CHI�??s Inaugural Targeting Diabetes with Novel Therapeutics

CHI�??s Sixth Annual RNAi for Screening: How to Best Utilize RNAi as a Screening Tool CHI�??s Second Annual RNAi for Therapeutics: How to Best Transition From the Lab to the Clinic CHI�??s Second Annual Kinase Inhibitors: Moving Forward into Clinical Studies CHI�??s Third Annual Ion Channels as Therapeutic Targets A Flood of Potential for Drug Discovery CHI�??s Second Annual HDAC Inhibitors: Targeting Oncology and Beyond Developing Candidates for Targeted Therapies CHI�??s Inaugural Targeting Diabetes with Novel Therapeutics Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=470 2008-10-01T06:11:11+01:00 2008-10-01T06:11:11+01:00 2008-10-01T06:11:11+01:00

This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. Description This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics. Areas Covered in the seminar: * Overview of the Clinical Trials Process, Phase I-IV studies including principles of working in a regulated environment; discuss FDA regulation, good clinical practice (GCP), and ICH Guidelines and Overview of IND/IDE process. * Ethics of clinical trials including historical background, current issues and current Regulatory observations. * Essential study documents that are required before trial initiation, during trial conduct and study close-out. Who will benefit: This webinar will provide valuable assistance to all personal in: * Pharmaceutical * Biotechnology * CROs

This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. Description This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics. Areas Covered in the seminar: * Overview of the Clinical Trials Process, Phase I-IV studies including principles of working in a regulated environment; discuss FDA regulation, good clinical practice (GCP), and ICH Guidelines and Overview of IND/IDE process. * Ethics of clinical trials including historical background, current issues and current Regulatory observations. * Essential study documents that are required before trial initiation, during trial conduct and study close-out. Who will benefit: This webinar will provide valuable assistance to all personal in: * Pharmaceutical * Biotechnology * CROs Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=469 2008-10-01T06:10:02+01:00 2008-10-01T06:10:02+01:00 2008-10-01T06:10:02+01:00

This session will explore the principles of risk management and its application outside the product safety environment for which ISO 14971 was specifically developed. Description This webinar will provide guidance to those responsible for managing projects and product development as well as those managing business risks. ISO 14971 is the risk management standard for medical devices that provides guidance in providing the safest possible medical devices. It is directed to product risk management, but is based on recognized principles of risk management. Currently, the ISO Technical Management Board is directing the development of a standard in the ISO 31000 series that will take these principles and apply them more generally towards business. We will discuss how a company can now take these principles and apply them to other areas of the business. The webinar will discuss the defining of acceptable risk and the analysis process of risk to determine if the company can proceed with the risk. Areas Covered in the seminar: * This session will explore the principles of risk management and its application outside the product safety environment for which ISO 14971 was specifically developed. * How to establish risk is acceptability standards in a company. * How to analyze specific risks against the acceptability standard. * Providing mitigation measures for risk and determining if risk is reduced to the acceptable level. * Who will benefit: This webinar will provide guidance to those responsible for managing projects and product development as well as those managing business risks. * Project Managers * Product Development Managers * Business Risk Managers

This session will explore the principles of risk management and its application outside the product safety environment for which ISO 14971 was specifically developed. Description This webinar will provide guidance to those responsible for managing projects and product development as well as those managing business risks. ISO 14971 is the risk management standard for medical devices that provides guidance in providing the safest possible medical devices. It is directed to product risk management, but is based on recognized principles of risk management. Currently, the ISO Technical Management Board is directing the development of a standard in the ISO 31000 series that will take these principles and apply them more generally towards business. We will discuss how a company can now take these principles and apply them to other areas of the business. The webinar will discuss the defining of acceptable risk and the analysis process of risk to determine if the company can proceed with the risk. Areas Covered in the seminar: * This session will explore the principles of risk management and its application outside the product safety environment for which ISO 14971 was specifically developed. * How to establish risk is acceptability standards in a company. * How to analyze specific risks against the acceptability standard. * Providing mitigation measures for risk and determining if risk is reduced to the acceptable level. * Who will benefit: This webinar will provide guidance to those responsible for managing projects and product development as well as those managing business risks. * Project Managers * Product Development Managers * Business Risk Managers Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=468 2008-10-01T06:09:01+01:00 2008-10-01T06:09:01+01:00 2008-10-01T06:09:01+01:00

This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process. "How to Develop and Maintain a Compliant Document Management/Control System" has been pre-approved by RAPS as eligible for up to 1 credit towards a participant�??s RAC recertification upon full completion. Description This webinar will provide valuable assistance to all regulated companies that are interested in learning about the requirements for a document control system, and spending less time on its implementation and performance. It is well known that document control is a critical requirement for FDA-regulated companies. However, document control can be a time- and paper-consuming process, in which even the simplest of changes requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. The best document control systems are those that are fast and effective. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process - Many companies can spend MUCH LESS preparing MANY FEWER documents, and still be in compliance with the regulations; is yours one of these? Areas Covered in the seminar: * QSR and ISO 13485 requirements for document control. * Description of typical document control system in use. * Streamlined document control process. * Paper-free document review. * Immediate document distribution. Who will benefit: This webinar will provide valuable assistance to all regulated companies that are interested in learning about the requirements for a document control system, and spending less time on its implementation and performance. The employees who will benefit include: * Executive/senior management * Document Control Management * Document Control Clerks * Quality system auditors * Consultants

This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process. "How to Develop and Maintain a Compliant Document Management/Control System" has been pre-approved by RAPS as eligible for up to 1 credit towards a participant�??s RAC recertification upon full completion. Description This webinar will provide valuable assistance to all regulated companies that are interested in learning about the requirements for a document control system, and spending less time on its implementation and performance. It is well known that document control is a critical requirement for FDA-regulated companies. However, document control can be a time- and paper-consuming process, in which even the simplest of changes requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. The best document control systems are those that are fast and effective. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process - Many companies can spend MUCH LESS preparing MANY FEWER documents, and still be in compliance with the regulations; is yours one of these? Areas Covered in the seminar: * QSR and ISO 13485 requirements for document control. * Description of typical document control system in use. * Streamlined document control process. * Paper-free document review. * Immediate document distribution. Who will benefit: This webinar will provide valuable assistance to all regulated companies that are interested in learning about the requirements for a document control system, and spending less time on its implementation and performance. The employees who will benefit include: * Executive/senior management * Document Control Management * Document Control Clerks * Quality system auditors * Consultants Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=467 2008-10-01T06:07:50+01:00 2008-10-01T06:07:50+01:00 2008-10-01T06:07:50+01:00

This webinar covers the current FDA requirement that all raw materials that are received and used in producing APIs & Drug Products should be qualified using a system to ensure that raw materials are of acceptable identity, quality purity before use. Description During the last several years, FDA has issued numerous observations and warning letters to pharmaceutical and biotechnology companies for lack of adequate systems for evaluating the suppliers of raw materials and the components, to ensure that these materials are acceptable for use. It is the FDA requirement that all raw materials that are received and used in producing APIs and Drug Products should be qualified using a system to ensure that raw materials are of acceptable identity, quality and purity before use. Areas Covered in the seminar: * Establish appropriate specifications for these materials and to assure your suppliers provide materials meeting these specifications. * Have the specifications be approved by the quality unit. * Ensure that raw materials received are suitable and approved by the quality unit prior to use. * Set a vendor qualification program that provide adequate evidence that the manufacturer can consistently provide reliable and safe materials. * Audit, monitored and regularly scrutinized the suppliers to assure ongoing reliability. * We will also review FDA 483s and Warning Letters relating to this topics. Who will benefit: * Pharmaceutical * Biotechnology industries

This webinar covers the current FDA requirement that all raw materials that are received and used in producing APIs & Drug Products should be qualified using a system to ensure that raw materials are of acceptable identity, quality purity before use. Description During the last several years, FDA has issued numerous observations and warning letters to pharmaceutical and biotechnology companies for lack of adequate systems for evaluating the suppliers of raw materials and the components, to ensure that these materials are acceptable for use. It is the FDA requirement that all raw materials that are received and used in producing APIs and Drug Products should be qualified using a system to ensure that raw materials are of acceptable identity, quality and purity before use. Areas Covered in the seminar: * Establish appropriate specifications for these materials and to assure your suppliers provide materials meeting these specifications. * Have the specifications be approved by the quality unit. * Ensure that raw materials received are suitable and approved by the quality unit prior to use. * Set a vendor qualification program that provide adequate evidence that the manufacturer can consistently provide reliable and safe materials. * Audit, monitored and regularly scrutinized the suppliers to assure ongoing reliability. * We will also review FDA 483s and Warning Letters relating to this topics. Who will benefit: * Pharmaceutical * Biotechnology industries Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=466 2008-10-01T06:06:38+01:00 2008-10-01T06:06:38+01:00 2008-10-01T06:06:38+01:00

This presentation will give an overview of the FDAAA and summarize the new provisions pertaining to specialized pediatric medical device development, food safety, advisory committee provisions, clinical trial registries and drug safety enhancement. Description On September 27, 2007, the President signed into law the most recent amendments and reauthorized some existing provisions in what is called the Food and Drug Administration Amendments Act (FDAAA) of 2007. The FDAAA adds many new provisions to the FD&C Act and provides important resources and adds strength to the FDA's ability and commitment to safeguard and advance public health. This presentation will give an overview of the FDAAA and summarize the new provisions pertaining to specialized pediatric medical device development, food safety, advisory committee provisions, clinical trial registries and drug safety enhancement provisions. Areas Covered in the seminar: * Reauthorization of existing laws. * Reagan-Udall Foundation. * Improved Clinical Trial Databases and Requirements. * Clinical Trial Registry Requirements . * FDA's new authority to address post market and surveillance issues concerning medical products. * New food safery provisions. * Advisory Committee provisions. * New user fee program to support FDA review of direct to consumer advertising. Who will benefit: This webinar will provide valuable information to those who develop and market Medical Devices, Pharmaceuticals for both adults and children, Biologics and those engaged in the manufacture and distribution of food. * Regulatory Affairs officials in the FDA regulated industries * Those personnel engaed in Clinical trials and the sponsors of clinical trials * Medical Researchers

This presentation will give an overview of the FDAAA and summarize the new provisions pertaining to specialized pediatric medical device development, food safety, advisory committee provisions, clinical trial registries and drug safety enhancement. Description On September 27, 2007, the President signed into law the most recent amendments and reauthorized some existing provisions in what is called the Food and Drug Administration Amendments Act (FDAAA) of 2007. The FDAAA adds many new provisions to the FD&C Act and provides important resources and adds strength to the FDA's ability and commitment to safeguard and advance public health. This presentation will give an overview of the FDAAA and summarize the new provisions pertaining to specialized pediatric medical device development, food safety, advisory committee provisions, clinical trial registries and drug safety enhancement provisions. Areas Covered in the seminar: * Reauthorization of existing laws. * Reagan-Udall Foundation. * Improved Clinical Trial Databases and Requirements. * Clinical Trial Registry Requirements . * FDA's new authority to address post market and surveillance issues concerning medical products. * New food safery provisions. * Advisory Committee provisions. * New user fee program to support FDA review of direct to consumer advertising. Who will benefit: This webinar will provide valuable information to those who develop and market Medical Devices, Pharmaceuticals for both adults and children, Biologics and those engaged in the manufacture and distribution of food. * Regulatory Affairs officials in the FDA regulated industries * Those personnel engaed in Clinical trials and the sponsors of clinical trials * Medical Researchers Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=463 2008-10-01T05:49:49+01:00 2008-10-01T05:49:49+01:00 2008-10-01T05:49:49+01:00

This course provides a process to overcome challenges for Documentation and Conducting CAPA Investigations and integrates FDA requirements and guidelines. "Documenting & Conducting CAPA Investigations" has been pre-approved by RAPS as eligible for up to 1 credit towards a participant�??s RAC recertification upon full completion. Description This course is appropriate for all who are regularly called upon to resolve problems, or whose input would aid in preventing problems. Accurate and thorough documentation and a process for conducting investigations is critical in an FDA regulated environment. The challenge is to capture necessary information in a timely fashion from a diverse workforce of individuals with technical and non-technical backgrounds. This course provides a process to overcome that challenge. Documenting and Conducting CAPA Investigations integrates FDA requirements and guidelines while focusing on effective documentation, data collection, and understandable language necessary for successful investigations. Areas Covered in the seminar: * Effectively expedite investigations. * Document investigations appropriately for the intended audience. * Assure that all necessary data/information is collected and documented. * Overlay the FDA�??s requirements and expectations related to conducting and documenting investigations. * Construct an effective report. * Attain a thorough understanding of the FDA�??s requirements and expectations related to conducting and documenting investigations. * Prepare clear, concise and effective documentation of investigations. * Improve communication and teamwork. Who will benefit: This course is appropriate for all who are regularly called upon to resolve problems, or whose input would aid in preventing problems. * Engineers * Investigators * Laboratory QA * Manufacturing Supervisors * Technicians

This course provides a process to overcome challenges for Documentation and Conducting CAPA Investigations and integrates FDA requirements and guidelines. "Documenting & Conducting CAPA Investigations" has been pre-approved by RAPS as eligible for up to 1 credit towards a participant�??s RAC recertification upon full completion. Description This course is appropriate for all who are regularly called upon to resolve problems, or whose input would aid in preventing problems. Accurate and thorough documentation and a process for conducting investigations is critical in an FDA regulated environment. The challenge is to capture necessary information in a timely fashion from a diverse workforce of individuals with technical and non-technical backgrounds. This course provides a process to overcome that challenge. Documenting and Conducting CAPA Investigations integrates FDA requirements and guidelines while focusing on effective documentation, data collection, and understandable language necessary for successful investigations. Areas Covered in the seminar: * Effectively expedite investigations. * Document investigations appropriately for the intended audience. * Assure that all necessary data/information is collected and documented. * Overlay the FDA�??s requirements and expectations related to conducting and documenting investigations. * Construct an effective report. * Attain a thorough understanding of the FDA�??s requirements and expectations related to conducting and documenting investigations. * Prepare clear, concise and effective documentation of investigations. * Improve communication and teamwork. Who will benefit: This course is appropriate for all who are regularly called upon to resolve problems, or whose input would aid in preventing problems. * Engineers * Investigators * Laboratory QA * Manufacturing Supervisors * Technicians Biofind http://www.biofind.com/ info@biofind.com http://www.biofind.com/Events/View.aspx?ID=461 2008-10-01T05:46:27+01:00 2008-10-01T05:46:27+01:00 2008-10-01T05:46:27+01:00

This presentation reviews the major areas described in FDA 21 CFR Part 58, particularly emphasizing the five key elements of preclinical studies: written procedures, personnel, equipment, data collection, and reporting. "Reading Between the Lines: Dealing with Gaps in GLP Regulations" has been pre-approved by RAPS as eligible for up to 1 credit towards a participant�??s RAC recertification upon full completion. Description This webinar is targeted to scientists and management new to GLPs. The Good Laboratory Practice regulations instituted by the FDA in the 1970s were developed to ensure the accuracy and integrity of preclinical drug and device studies. These GLPs consist of certain simple but defined methods for assuring that test articles are safe and effective before being tested in clinical studies. This presentation reviews the major areas described in FDA 21 CFR Part 58, particularly emphasizing the five key elements of preclinical studies: written procedures, personnel, equipment, data collection, and reporting. The key roles of the QAU, study director and management are reviewed. Areas Covered in the seminar: * Why the GLPs were written. * The major sections of 21 CFR Part 58. * Protocols, amendments, and deviations. * Good data documentation. * The basics of an effective SOP system. * Final report requirements. * The principles of data and sample chain-of-custody. Who will benefit: This webinar is targeted to scientists and management new to GLPs. This includes established companies, startups, and university laboratories conducting sponsored regulated studies. The following individuals will benefit from the information in this webinar: * Study directors, contributing scientists, testing facility management, and study sponsors * QA managers and personnel * Analysts, technicians, and other study personnel * Consultants * Auditors

This presentation reviews the major areas described in FDA 21 CFR Part 58, particularly emphasizing the five key elements of preclinical studies: written procedures, personnel, equipment, data collection, and reporting. "Reading Between the Lines: Dealing with Gaps in GLP Regulations" has been pre-approved by RAPS as eligible for up to 1 credit towards a participant�??s RAC recertification upon full completion. Description This webinar is targeted to scientists and management new to GLPs. The Good Laboratory Practice regulations instituted by the FDA in the 1970s were developed to ensure the accuracy and integrity of preclinical drug and device studies. These GLPs consist of certain simple but defined methods for assuring that test articles are safe and effective before being tested in clinical studies. This presentation reviews the major areas described in FDA 21 CFR Part 58, particularly emphasizing the five key elements of preclinical studies: written procedures, personnel, equipment, data collection, and reporting. The key roles of the QAU, study director and management are reviewed. Areas Covered in the seminar: * Why the GLPs were written. * The major sections of 21 CFR Part 58. * Protocols, amendments, and deviations. * Good data documentation. * The basics of an effective SOP system. * Final report requirements. * The principles of data and sample chain-of-custody. Who will benefit: This webinar is targeted to scientists and management new to GLPs. This includes established companies, startups, and university laboratories conducting sponsored regulated studies. The following individuals will benefit from the information in this webinar: * Study directors, contributing scientists, testing facility management, and study sponsors * QA managers and personnel * Analysts, technicians, and other study personnel * Consultants * Auditors