Pulse on FXConferences

Measuring and Improving the Readability of Medical Device User Information

noreply@blogger.com (FxConferences) — Wed, 08 Feb 2012 21:08:00 +0000

is being presented by Cynthia M. Shalers, Writing, Editing & Design Consultant and airs on Tuesday, February 28th, 2012. For more details or to register, please visit our site at www.fxconferences.com

A concise, clearly written, readable user guide can mean the difference between a successful, happy customer and a frustrated, angry, or even endangered one. This audio conference approaches readability in medical-device documentation from two directions. First, our speaker explains how to achieve the reading level required by the FDA, providing attendees with the tools for measuring the reading level and adjusting it editorially. Second, she offers a variety of methods for increasing conciseness and simplicity in medical writing, which can be applied to any level of complexity to improve readability. The presentation also reviews graphical aspects that improve readability, such as the proper use of white space, leading, lists, and sidebars. Throughout the conference, the speaker uses specific examples from her own work and cites the relevant FDA guidance documents.

Food Industry Update – Responding to an FDA Form 483

noreply@blogger.com (FxConferences) — Mon, 06 Feb 2012 20:46:00 +0000

is being presented by Lisa Capote, Partner, with Arrastia & Capote LLP and airs on Thursday, February 23rd, 2012. For more details or to register, please visit our site at www.fxconferences.com

On January 4, 2011 President Obama signed into law the FDA Food Safety Modernization Act (FSMA). As part of the new regulation, FDA will provide oversight, ensure compliance with requirements and respond effectively when problems emerge. The FSMA mandates inspection frequency based on risk for food facilities, and requires the frequency of inspections to increase immediately. The law directs FDA to inspect at least 600 foreign food facilities within one year of enactment, and double those inspections every year for the next five years. Odds are, that will in turn lead to the issuance of a great deal of additional Form 483s to companies that have never before seen one, let alone had to respond to one.

This audio conference presentation provides detail on the FDA's plans for increased facility inspections, and looks at the most likely areas of scrutiny for inspectors in the coming months. Our speaker shares insight on the steps you can take to ensure a successful inspection, and, in the event your company receives a Form 483, how best to respond so as to avoid a re-inspection.

Monitoring Device Trials: Findings, Recommendations, Corrective Action Plans

noreply@blogger.com (FxConferences) — Thu, 02 Feb 2012 19:56:00 +0000

is being presented by JoAnn Tyson, CEO & Senior Clinical and Regulatory Affairs Director, with J. Tyson & Associates and airs on Wednesday, February 22nd, 2012. For more details or to register, please visit our site at www.fxconferences.com

Monitoring for a medical device trial can present unique challenges related to the complexity of the protocol, data capture tools, site personnel selection and limited oversight of subjects/data or procedures inconsistent with good clinical practices (GCP). However, proper monitoring can allow the sponsor/CRO to identify risks more readily and more clearly.

This audio conference presentation focuses on best practices for monitoring medical device trials, from the essential areas of focus during interim site visits to the proper training of monitors and other clinical personnel to ensure trial objectives are achieved. Our speaker also discusses compliance requirements and corrective action plans, and reviews the necessary steps in preparing for a successful regulatory body inspection.

Meeting the Linguistic Requirements for EMA Submissions

noreply@blogger.com (FxConferences) — Wed, 01 Feb 2012 20:09:00 +0000

is being presented by Anabel Pérez, Senior Project Manager, with ForeignExchange Translations and airs on Tuesday, February 21st, 2012. For more details, or to register please visit our site at www.fxconferences.com

Translating product information documents in preparation for an EMA submission can be a frustrating, complex and lengthy process for both pharmaceutical companies and their translation providers. However, by establishing and maintaining communication from the start of the project, and by working together to establish realistic timelines and achievable milestones, many of the common headaches can be avoided.

In this audio conference presentation, our speaker outlines the pain points often encountered when translating for an EMA submission, and proposes solutions, innovations and best practices that will allow client and supplier to work together collaboratively to meet all the EMA requirements, and make for a smoother submission.

Turning Technical Experts into Great Leaders

noreply@blogger.com (FxConferences) — Tue, 31 Jan 2012 19:29:00 +0000

is being presented by Leigh Bailey, Founder & CEO, of The Bailey Group and airs on Thursday, February 16th, 2012. For more details or to register, please visit our site at www.fxconferences.com

Technical leaders can be defined as those who are experts in a particular specialty (e.g. engineering, nursing, medicine, finance, law, or accounting), and whose career paths have changed from a technical/individual contributor track to a management track. In many cases, they are promoted to management because of their success as individual contributors – partly as a reward for their history of good work and partly because it is assumed they will teach their direct reports to be as gifted as they are at their technical specialty.

In such situations, it does not take long for problems to arise with newly appointed managers. Direct reports often claim that the new manager is a “micro manager” and they cannot do their work well enough to earn his or her praise. Peers may complain that the new manager is condescending, doesn’t listen, or jumps to false conclusions. Most damaging is when the new manager does not think anything is wrong and dismisses the feedback from his or her colleagues. Left unchecked, these situations often lead to the boss deciding that the “collateral damage” created by these new managers is too great and they are returned to their individual contributor role, ego and reputation badly damaged.

These kinds of situations are entirely avoidable, and this presentation looks at how to identify good candidates for technical leadership, how to spot individuals who are less likely to succeed, and how to work with existing technical leaders to maximize their chances for success.

The De Novo Petition – Is There Hope at FDA for Lower Risk, Innovative Devices?

noreply@blogger.com (FxConferences) — Mon, 30 Jan 2012 20:46:00 +0000

is being presented by Michael A. Swit, Principal, with Law Offices of Michael A. Swit and airs on Wednesday, February 15th, 2012. For more details, or to register please visit our site at www.fxconferences.com

The 'de novo' 510(k) petition process presents a unique opportunity for medical device companies to bring products to the market without having to go through the more lengthy and expensive route of a Premarket Approval Application (PMA).

In 1997, recognizing that many innovative devices put into Class III presented lower risks, Congress revised the medical device laws to create the de novo petition. It allows a company to petition FDA to move a device that has been automatically classified into Class III to Class II or even Class I. While designed to relieve the regulatory burden on industry, the de novo petition process has presented many challenges. Less than 70 devices have successfully undergone the de novo process. And, the process is not easy. Before pursuing a petition, a firm must first file a 510(k) and have FDA deny the submission as not substantially equivalent.

In late 2011, FDA issued a new draft guidance on the de novo process, and legislation is pending that would streamline the system. This audio conference explores how to take advantage of the de novo process, challenges linked to the process and how to best position your petition for success.

The Food Safety Modernization Act – What It Really Means (And What It Doesn't)

noreply@blogger.com (FxConferences) — Fri, 27 Jan 2012 18:41:00 +0000

is being presented by Benjamin L England, Founder and CEO, of FDAImports.com and airs on Wednesday, February 15th, 2012. For more details or to register, please visit our site at www.fxconferences.com

Since its introduction, the Food Safety Modernization Act has been discussed, written about and portrayed ad infinitum, often out of any sensible context to the actual realities of importing and manufacturing. Hyperbole aside, what does it really mean for you and your company?

With this timely audio conference presentation, former FDA veteran Benjamin England brings a much-needed reality check to the FSMA conversation. The presentation looks at what FSMA implementation this year will likely consist of, and what specific issues are likely to arise based on these new rules in a real-world context. For manufacturers, companies and distributors this means valuable insight into which changes should be of concern, what can safely be ignored, what they can expect in the coming months, and how best to prepare. Mr. England devotes special attention to the implementation dates for 2012, and provides attendees with an opportunity to ask questions specific to their situation.

Who Owns What? Patent Ownership Issues with the Exchange of Biotechnology

noreply@blogger.com (FxConferences) — Thu, 26 Jan 2012 19:40:00 +0000

is being presented by Kattina V. Barsik, Esq. Intellectual Property and Registered Patent Attorney and airs on Tuesday, February 14th, 2012. For more details, or to register please visit our site at www.fxconferences.com

Institutions involved in the exchange of unique materials – including federal laboratories, industrial research laboratories, and laboratories in universities, hospitals, or independent research institutes – often have specific expectations regarding compensation for the help they provide. It may range from acknowledgment in a publication to ownership of inventions made with the aid of the provided material.

Industry defends its commercial interests vigorously, and seeks to offset risk by acquiring and protecting exclusivity in the marketplace through patent law or by use of trade secrets. In contrast, the federal government and its academic grantees look to preserve the flow of ideas for public benefit, primarily through timely publication, and to serve as the public's steward of inventions by preserving the potential for new knowledge to generate a product from which the public may benefit. The exchange of materials between universities and industrial laboratories is often difficult, and unlikely to be standardized in the near future.

This audio conference presentation discusses how to deal with these competing priorities, and craft terms which avoid conflict and allow all parties to benefit.

The UK Bribery Act– Upping the Ante on Anti-Corruption/Anti-Bribery Enforcement

noreply@blogger.com (FxConferences) — Wed, 25 Jan 2012 19:43:00 +0000

is being presented by Jamie L. Kendall, Esq., Senior Director, with Compliance Implementation Services and airs on Thursday, February 9th, 2012. For more details or to register, please visit our site at www.fxconferences.com

Since 1977, international pharmaceutical manufacturers have had to ensure their local affiliates abide by the Foreign Corrupt Practices Act (FCPA) when interacting with government officials. Just this past April, Johnson & Johnson came to settlement terms with the SEC for FCPA charges to the tune of $48.6 million stemming from allegations of bribing and providing kickbacks to public doctors in Europe and Iraq.

In 2010, the United Kingdom threw its hat into the anti-corruption/anti-bribery ring by enacting the UK Bribery Act, which went into effect July 1, 2011. In an interview with the Daily Telegraph the day it went into effect, the director of the UK Serious Fraud Office emphasized the intention to use the UK Bribery Act to go after non-UK corporations. While most companies may be familiar with best practices to avoid criminal investigations and civil penalties under the FCPA, the UK Bribery Act creates an additional layer of scope and raises the floor of compliance by including parties and actions not contemplated by the FCPA.

Pharmaceutical companies with UK connections will no longer be able to rely on anti-corruption policies and procedures that were predicated solely on FCPA compliance. Indeed, such policies and procedures must now account for the wider net that the UK Bribery Act casts. The enactment of the UK Bribery Act increases fraud and abuse risk exposure and an understanding of its provisions and how it differs from the FCPA is essential for creating a comprehensive compliance policy.

This presentation provides attendees with an overview of the differences between the UK Bribery Act and the FCPA and emphasizes the wider scope the UK Bribery Act represents in the anti-corruption/anti-bribery regulatory and legal framework.

Patient Recruitment: How It's Broken and Five Ways to Fix It

noreply@blogger.com (FxConferences) — Tue, 24 Jan 2012 20:54:00 +0000

is being presented by Sherry Reuter, President, of Sherry Reuter & Associates and airs on Wednesday, February 8th, 2012. For more details, or to register please visit our site at www.fxconferences.com

The numbers don't lie: clinical trial enrollment rates have dropped from 75% in 2000 to 59% in 2006 and retention rates have fallen from 69% to 48% during same period; delays in patient recruitment for clinical trials account for an average of 4.6 months lost per trial – an annual cumulative loss of 26 years, on average, for each company; 80% of total trials are delayed at least one month because of unfulfilled enrollment.

The bottom line? Patient recruitment as we know it just isn't working.

This audio conference presentation looks at the efforts currently used to reach recruitment goals, why they are ineffective, and why new approaches must be implemented. Our speaker shares specific strategies that can be easily implemented, and helps attendees understand the patient's perspective and how to use that awareness to make recruitment plans more effective.

Medical Device Software – Regulatory Requirements and Issues

noreply@blogger.com (FxConferences) — Mon, 23 Jan 2012 20:20:00 +0000

is being presented by Neil R. Armstrong, CEO, of MeddiQuest and airs on Tuesday, February 7th, 2012. For more details, or to register please visit our site at www.fxconferences.com

Healthcare is being revolutionized through the synergistic development of information technology and medical devices, and regulators are starting to realize that healthcare software cannot be ignored or adequately regulated by analogy to hardware alone. However, there is little consistency in the extent or content of new regulations being introduced.

This audio conference presentation is targeted at those involved in developing medical devices with software, or software to be used in a healthcare environment, who want a high-level overview of the regulatory landscape and a better understanding of current issues. Our speaker discusses the evolution of medical device software regulations, summarizing the current regulatory requirements in major markets. We also explore some forthcoming issues, and how current product development can be “future-proofed” against new regulations.

Improving Compliance and Patient Safety with Plain Language Authoring

noreply@blogger.com (FxConferences) — Tue, 17 Jan 2012 20:31:00 +0000

is being presented by Kristina E. Anderson, EasyRead Writing LLC and airs on Wednesday, February 1st, 2012. For more details, or to register please visit our site at www.fxconferences.com

The Plain Writing Act of 2010 is the latest government effort to make complicated regulations easier to read and understand. "Plain language" refers to a method of authoring documentation in a straightforward, sensible, engaging and culturally appropriate manner. It makes the complicated easier to grasp. It tells readers what they need to know and nothing else. When done correctly, it ensures understanding and compliance and improves patient safety – and now it's the law! What plain language is not, is the "dumbing down" of information.

Authoring your documentation using plain language can result in a savings of both time and money by reducing mistakes and misunderstandings. However, successful implementation requires buy-in on an organization-wide level, and there can be some resistance to change. This audio conference presentation is designed to provide attendees with an understanding of what plain language is, how and why to start using it, and what the Plain Writing Act of 2010 means for your company. It also provides regulatory writers with the compelling information they need to convince managers that plain language authoring is a valid and necessary development in health care.

7 Critical FDA Expectations of Senior Management

noreply@blogger.com (FxConferences) — Mon, 16 Jan 2012 20:59:00 +0000

is being presented by John Avellanet, Managing Director & Principal, with Cerulean Associates LLC and airs on Tuesday, January 31st, 2012. For more details or to register, please visit our site at www.fxconferences.com

The FDA is cracking down on corporate executives, using the Park Doctrine and the FDAAA to impose civil penalties, jail time and industry bans.

This audio conference presentation focuses on the things your management team needs to be doing on a regular, consistent basis to 'ensure the suitability and effectiveness' of your company's quality system. Our speaker, who is president of an independent review organization (IRO) for a current consent decree, provides insight on what FDA investigators and district officers expect to see from your management team. Attendees discover the crucial difference in the eyes of FDA between responsibility and accountability, and how it affects delegating work to staff and suppliers. The presentation also discusses how to ensure your management team is effectively and appropriately engaged, and what proof you need to provide the agency investigators.

Preparing for 2012: Regulatory Update for Device & Diagnostic Companies

noreply@blogger.com (FxConferences) — Fri, 13 Jan 2012 19:34:00 +0000

is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Tuesday, January 31st, 2012. For more details, or to register please visit our site at www.fxconferences.com

2011 was quite a year for publishing proposed major changes to the regulatory framework for medical device and diagnostics manufacturers. It is likely that more certainty will be introduced during 2012 as to what the changes will be and how they will affect MD&D companies. The major topics include the 510K process in the US, the planned recast of the Medical Device Directives in the EU, potential changes to the informed consent process for sample collection in the US, planned changes to the monitoring guidance in the US, and the changes to the ISO 14155 standard issued in 2011.

In this audio conference, our speaker reviews the changes or proposed changes to the regulatory framework, discusses the implications for MD&D companies, and describe how best to plan for future changes. The presentation also provides pointers on when the changes currently in draft form are likely to be implemented. This audio conference is intended to summarize the 2011 regulatory landscape for MD&D companies, and help them prepare for 2012 and beyond.

Food Defense – Regulatory Requirements and New Developments

noreply@blogger.com (FxConferences) — Tue, 10 Jan 2012 19:52:00 +0000

is being presented by William L Ramsey, Director of Security, with McCormick & Company and airs on Thursday, January 26th, 2012. For more details or to register, please visit our site at www.fxconferences.com

The safety and security of the food supply has come under intense scrutiny in the wake of 9/11. In the intervening years "food defense" has become an industry catchphrase. But what exactly does it mean? What do regulators want to see?

This audio conference presentation reviews the use of physical security practices in the food industry since the events of September 11, 2001 and the advent of the term “food defense”. Our speaker discusses current food defense expectations from both the USDA and FDA, and takes a look at some possible regulatory developments associated with the Food Safety Modernization Act of 2010.

The presentation provides key information on the use of threat assessments, vulnerability assessments and risk assessments, as well as the use of a “goal based” security model in the development of security and food defense plans for food manufacturing facilities. Attendees also learn about supply chain responsibilities, and ways to utilize national and international supply chain programs such as C-TPAT, AEO and PIP to enhance food defense measures.

An Overview of Recent Risk-based Monitoring Guidance from the FDA

noreply@blogger.com (FxConferences) — Mon, 09 Jan 2012 20:50:00 +0000

is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, January 25th, 2012. For more details, or to register please visit our site at www.fxconferences.com

We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.

These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.

Collecting Post-Market Device Data Without Running Afoul of FDA

noreply@blogger.com (FxConferences) — Fri, 06 Jan 2012 19:51:00 +0000

is being presented by Robert J. Klepinski, Regulatory Attorney, with Fredrikson & Byron and airs on Thursday, January 19th, 2012. For more details, or to register please visit our site at www.fxconferences.com

Most medical device companies today wish to gather data on product use and performance without being entangled in expensive IDE negotiations. However, recent FDA enforcement actions have brought new scrutiny to post-market studies. FDA has combined accusations of off-label promotion with enforcement against studies collecting data on usage deemed to be outside cleared labeling. So what are device manufacturers to do? Is there still a path available for collecting this important information? This audio conference explores the regulations involved, recent enforcement actions by FDA, the difficulties in ascertaining the scope of indications today, and ways to gather information within the current enforcement environment.

Voice of the Customer: The First Step in Human Factors Engineering

noreply@blogger.com (FxConferences) — Wed, 04 Jan 2012 20:47:00 +0000

is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Tuesday, January 17th, 2012. For more details, or to register please visit our site at www.fxconferences.com

The medical device industry faces a unique challenge; R&D professionals develop products but rarely get a chance to use them, while quality departments lack the data to translate customer needs and marketing specifications into technical requirements and metrics. To compound the issue, FDA will soon have its final HFE Guidance in place, and all device products and companies will have to comply.

Voice of the Customer (VOC) allows device manufacturers to immerse product design teams in the customer’s culture and environment, and this audio conference presentation looks at how to use the VOC process to collect and analyze customer data and integrate it into the design process. Attendees learn how to develop market surveys and other tools to assess the needs of customers, and how to define and categorize customer issues with products. Our speaker discusses the relationship between VOC and HFE principles, and shares critical techniques for new product and product improvement initiatives.

Addressing Cost Pressures in Late-Phase Research

noreply@blogger.com (FxConferences) — Thu, 15 Dec 2011 20:25:00 +0000

is being presented by Dr. Max Horneck, Head of eClinical Services, with Wega Informatik AG and airs on Thursday, January 19th, 2012. For more details, or to register please visit our site at www.fxconferences.com

There is no question that gathering real-life data on approved drug products is of vital importance. Data collected for marketed drugs is needed to generate thorough knowledge of the safety, efficacy and effectiveness. The challenge for clinical operations arises from significant cost pressure in post-authorization studies, while attempting to maintain an adequate level of quality and achieving study targets. Experience has shown that simply mapping procedures from early to late phase does not give the desired results. Budgets tend to be overstressed while targets and quality remain in danger.

In this audio conference, our speaker draws upon almost two decades of clinical experience and provides insight on how to to effectively maintain control of the study conduct and quality of data with reduced efforts by the use of risk mitigation, regional service providers and business intelligence. This presentation enables the attendees to safely plan and conduct late phase studies at significantly reduced costs while maintaining compliance with current regulations at the desired level of quality.

eLabeling Medical Devices for the EU Market

noreply@blogger.com (FxConferences) — Wed, 07 Dec 2011 20:04:00 +0000

is being presented by Salma Michor, CEO and Principal Consultant, with Michor Consulting EU and airs on Tuesday, January 10th, 2012. For more details, or to register please visit our site at www.fxconferences.com

Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.

In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.

Best Practices for Successfully Implementing a Global Content Management System

noreply@blogger.com (FxConferences) — Tue, 06 Dec 2011 20:43:00 +0000

is being presented by Jason Arnsparger, Solutions Development Consultant, with ForeignExchange Translations, Inc. and airs on Thursday, January 12th, 2012. For more details or to register, please visit our site at www.fxconferences.com

Thinking about implementing a content management system? As the demand for technical, training, marketing documentation and product labeling increases, so too does the need to deliver this content more quickly and in more languages. To meet these requirements, many regulated companies are migrating towards structured authoring and content management systems that enable the re-use and re-purposing of existing content.

In this presentation, our speaker draws upon first-hand experience, first with a medical device company and more recently with a localization provider, and discusses tips, challenges, best practices and lessons learned with CMS implementations. Attendees receive valuable insight and hear first-hand how to reap the CMS benefits while minimizing implementation headaches.

Opportunities in the European Regulatory Framework for Orphan Medicinal Products

noreply@blogger.com (FxConferences) — Mon, 05 Dec 2011 19:16:00 +0000

is being presented by Dr. Maureen Graham, Managing Director, of Diamond BioPharm Limited and airs on Wednesday, January 11th, 2012. For more details, or to register please visit our site at www.fxconferences.com

The orphan drug regulation in Europe came into force over 10 years ago, with the aim of stimulating research and development of medicinal products for rare diseases. Obtaining and maintaining orphan status opens up a number of opportunities to companies developing such products, but it is crucial to have a thorough understanding of the orphan rules in Europe in order to fully benefit from the incentives offered.

This audio conference presentation provides an overview of the legislative framework, and highlights the incentives available. Our speaker focuses on the most important aspects that need to be considered when compiling an application for orphan designation, and how this may impact the development program. Finally, the presentation summarizes both the potential pros and cons will be summarized.

Developing Effective Quality Agreements: Legal and Regulatory Issues

noreply@blogger.com (FxConferences) — Thu, 01 Dec 2011 19:29:00 +0000

ia being presented by Alan Minsk, Partner, with Arnall Golden Gregory LLP and airs on Wednesday, December 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Supplier control has become a major focus area for FDA in recent years, and as such, an area which is seeing heightened enforcement efforts. This represents a significant challenge for medical device and pharmaceutical companies, who need to respond accordingly to ensure their supplier quality agreements will pass muster with FDA. The landscape is changing quickly, and those without the critical regulatory information will be ill-prepared for FDA scrutiny.

In this audio conference presentation, Alan G. Minsk, Partner and Chair of the Food and Drug Practice Team at Arnall Golden Gregory LLP, guides attendees through the critical points and the pitfalls to avoid when drafting quality agreements. The presentation addresses the vital legal and regulatory issues affecting pharmaceutical and medical device manufacturers, leaving attendees better prepared to meet customer and FDA expectations regarding supplier quality.

Risk and Reward – Using Social Media to Promote Medicinal Products in the EU

noreply@blogger.com (FxConferences) — Tue, 22 Nov 2011 20:08:00 +0000

is being presented by Elisabethann Wright, Hogan Lovells International LLP and airs on Tuesday, December 6th, 2011. For more details, or to register please visit our site at www.fxconferences.com

The Internet provides an ever-growing source of information, both for healthcare professionals and consumers, concerning medicinal products. Although many countries around the world have developed regulations intended to govern the promotion of medicinal products, the very nature of the Internet makes it difficult to police. There are both opportunities and risks for the pharma company engaging in promotion using social media. This audio conference presentation examines the laws currently in place in the European Union governing promotion of medicinal products, and how these apply to promotion on the Internet and, in particular, via social media. Our speaker also examines the risks pharmaceutical companies face when establishing corporate websites and social media accounts.

Best Approaches for Your 510(k) Submission

noreply@blogger.com (FxConferences) — Mon, 21 Nov 2011 19:19:00 +0000

is being presented by F. David Rothkopf, President, of MEDIcept and airs on Tuesday, November 22nd, 2011. For more details or to register, please visit our site at www.fxconferences.com

There has been a lot of news lately – both positive and negative – about the FDA’s 510(k) medical device clearance process. FDA, Congress, and many third parties are reviewing the process for efficiency and effectiveness. The FDA has hired many new reviewers, but training has been slow. They have released new guidance documents relating to 510(k) submission components, but they are radically different than the previous interpretation of the requirements.

The result of all this change has been that review times have increased by 65 percent since 2005, and the number of reject decisions – not substantially equivalent, NSE determinations – increased from a historic level of 3.5 percent to 8 percent of 510(k) submissions during the 2010 fiscal year.

This is the new normal. Even if you sent in a submission two years ago, it might not be acceptable now. So what exactly does FDA want to see in your 510(k) submission, and how do medical device manufacturers cope with this new reality?