Interview candidates must be well prepared with all the job requirements

I have created a hypothetical model in which a persons Pharmaceutical education along with a bachelors degree in life sciences contributes 20% of what I have called the “acceptance grade”. Most  jobs in Regulatory Affairs require a Bachelors degree in life sciences and a certificate/Diploma showing pharmaceutical training.  You will most likely not be invited for interview if you don’t have a  Bachelors degree.

I have allocated a maximum of 40% of the “acceptance grade” to experience for an advertised post that requires 5 years experience. The highest “acceptance grade” is awarded to a candidate with 5 years experience. A candidate with 1 year experience gets only  8%.  See table below to see how years of experience influence the  final acceptance grade.

Relevant skills,knowledge,personal attributes such attitude and reliability that  help the applicant to do  the job well contribute 40% to the acceptance grade. In this example we have 15 essential job requirements.  The list may vary from one job to another. My purpose is to illustrate that the requirements in job postings should be treated seriously. If you claim to have a skill you don’t have, the interviewing panel will find out and you may be classified as unreliable and dishonest. Be truthful and they will respect you for it.

Some people attend and fail many interviews because they lack an eye for detail, lack follow up skills, can’t work independently, aren’t good team players, appear to be unreliable and lack problem solving abilities. Unfortunately these skills and personal attributes cannot be acquired easily through pharmaceutical education alone. They may take a longer time to develop than taking a course. Some of them  depend on your character and personality such as being a  “team player”. You have to identify your own short comings. Be honest with yourself and plan to change or look for a job that matches your skills.

What about  reading, writing  and speaking skills? If your native language is not English , these English skills may take longer to acquire than others. They can however be acquired if you have a plan. We may be able to help if you contact us.

Column A below shows an example of the ideal candidate with all the listed qualifications and job requirements plus 5 years experience in regulatory affairs  as advertised. In real life it’s hard to come across many such a candidates. You may qualify for interview even though you lack one or 2 job advertised requirements provided you excel in other areas.

When having advertised job requirements and experience trumps over certificates and diplomas

Columns D, E & N in the table below shows candidates with all the listed skills and 3,4 or 5 years of experience but don’t have a diploma or a certificate showing pharmaceutical education.

These candidates score 77%, 85% and 93% respectively and have a high chance of being employed. In addition to other skills, these candidates have transferable skills and attributes such as good communication skills, problem solving skills, follow up skills , reliable, team players, work independently and have an eye for detail.

As you can see having all the advertised job requirements and experience trumps over a certificate or diploma. A certificate/diploma is important but may not be adequate. For best results make sure that the certificate or diploma helps you to acquire most of the skills required in your area of interest.

We recommend that you acquire as many relevant skills as you can in your current job or training. This will help you a long the way when new opportunities arise.

Pharmaceutical education and experience

Columns B and C in the table below shows the effect of experience for a person who lacks Pharmaceutical Training. Two or more years of experience has a significant effect on the acceptance grade. A person without evidence of Pharmaceutical Education but with two years experience in the pharmaceutical industry  is more preferred than a person with no experience or with 1  year experience.

Column M in the table below shows that a person with no experience, no certificate or diploma has 53% of the acceptability criteria . Such a person may be invited for an interview if that person has a significant number of the essential job requirements.

Acquired skills trump over irrelevant experience

Columns A,B, F,G,H,I and J in the table below show how increasing the number of years of experience can bias the acceptability criteria despite the lack of essential skills. While a candidate may be invited for an interview they are unlikely to be hired because they lack the essential skills.

Lack of pharmaceutical Education and Experience

It’s possible to be hired without Pharmaceutical education training certificate/ diploma or much experience but you are unlikely to be hired if you don’t have the key job requirements. Column L in the table below shows that a person without Pharmaceutical Education certificate diploma or experience  but with only 7 of the 15 job requirements has only 35% of the “acceptance grade”. Such a person is unlikely to be invited for interview. Column N in the table below shows that a person without Pharmaceutical Education or experience but with  all the 15 job requirements has  53% of the acceptance grade. This person has better chance of being invited for interview than the person in column L.

Conclusion

If you would like to work in Regulatory Affairs and and play a significant role in submitting eCTDs to Health Canada or the FDA, consider taking an appropriate course in Regulatory Affairs. As mentioned above pharmaceutical education is essential for success in the pharmaceutical industry.

Learn the key skills that are common in jobs advertised. Improve on your personal attributes as described above.

If you don’t find a job immediately after the course, volunteer where you are likely to learn either transferable skills or job specific skills. As you volunteer prepare and  give your undivided loyalty to the organization as if you are employed there.  You will be remembered when you leave. You will also get a good reference. Work hard even if you are not being paid.

The lessons you learn while you volunteer will contribute towards  your “employability” .

We offer some online courses in Regulatory affairs. We also provide limited internship opportunities to those who graduate from our courses.

Education and Training for eCTD Publishing

Generally a Bachelor’s Degree in life sciences is required . In certain situations a bachelors degree in Chemistry might be required or acceptable. Usually a Regulatory Affairs certificate or a diploma from a private Career College or a community college is also required. If you are looking for an entry position do not ignore relevant training.  Any specialized training in eCTD format is acceptable if it provides you with the necessary skills required.

Experience in eCTD Publishing

Most jobs require at least 3 years of experience but this may be overlooked for good candidates with other skills described below. If you have experience in  paper publishing process you may be considered.  Typically you will be expected to know the process of publishing a new drugs submission, abbreviated new drug submission, responding to health Canada notices and other related activities. Although you will rarely compile a full submission alone except for generic products you are expected to understand the full process of a drug submission. Usually you will be given other responsibilities other than eCTD publishing.

Skills/Competencies

As many documents are prepared and submitted to regulatory agencies, you will be required to have knowledge of and experience in  formatting  documents. You will be required to have advanced skills in word processing  and publishing.

While you may not be expected to create xml files, experience with XML editors and publishing software such as Docubridge or similar software are required. You will need to know about eCTD publisher, viewer and Validator.

The job requires a strong understanding of the CTD structure. You must also have a strong understanding of  Health Canada,  FDA and ICH specifications relating to  eCTD submissions. These specifications are applied in the eCTD software.

In addition you must have a good knowledge of the pharmaceutical industry together with relevant regulations and guidance documents.

You must provide evidence during the interview or in your resume that you are committed to remain up to date in Canadian, USA and EU regulations if the company of interest is interested in those markets.

ECTD Publishing jobs require technical and soft skills

Typically you must have advanced skills in MS Word. You will often use it to create documents. Many people take this for granted and miss opportunities.

Ability to use professional  Adobe Acrobat or similar software  is a must for eCTD publishing . Some of the most important publishing skills include documents merging and splitting, creating bookmarks and hyperlinks among others.

While education and experience  are important, you may not pass the eCTD publishing  interview if you  don’t demonstrate that you have the skills described below. You must demonstrate that you have the ability to work independently without requiring much supervision. Sometimes you may have to work under pressure. This skill cannot be acquired in school but evidence can be provided from school related activities.

You must be able to prioritize tasks to meet   deadline. This is a transferable skill and it could be acquired in other jobs including customer support, office administration, teaching among others. You may be asked to proof with examples that you have this skill. Lack of this skill can result lose of the employment opportunity or  in financial lose by an employer.

You must also have  good organizational and problem-solving skills. If you are disorganized and can’t solve simple regulatory problems you will be disqualified during  the interview. You need this skill when problems come up the last minute before deadline. You may have to stay late to solve the problem.

You must also have follow-up skills. Quite often eCTD publishers will  rely on others for documents or information in the company. Without the ability to follow up you will not meet deadlines

You must also be able to pay attention to detail and generate  accurate and and reliable dossiers.

As you can eCTD publishing is not for anyone .

If you are you would like training in eCTD we have an online course. Contact us.

A related article will be published on this blog next week. Check it out.

Validation Software and eCTD Validation Rules

There are several types of  eCTD Validation software. They may differ in the way they apply ectd validation rules. Use of at least two of these validation software is recommended when you are preparing a dossier for submission. If sofware misses an error the other will probably catch it. Some of them may even be free. The validation software applies the eCTD validation rules in all your pdf files. It will check the pdf document for hyperlinks, password protection, pdf version, encrypted documents, and bookmarks among others. Error reports will be produced  for you to review and make corrections.

PDF versions

There are different versions of PDF.  Regulatory agencies from the ICH regions accept versions 1.4, 1.5, 1.6, and 1.7  of the PDF.

PDF documents should not have any attachments as this violates the eCTD validation rules.

Your PDF documents must not be Corrupt or unreadable

How do you know if a PDF file is corrupted or not? A PDF document will be considered as corrupted if at least one of the following occurs:

• The file cannot be opened or it is encrypted.
• Attempts to open it returns  0 pages.
• The document cannot be read.
• PDF viewer is unable to view the document

Magnification Setting for Bookmarks and hyperlinks

When creating bookmarks and hyperlinks you must first set the magnification setting “Inherit Zoom”.  It  is necessary that the destination page displays at the same magnification level  which the  reviewer  is using throughout the document. This helps in the review of your eCTD.

As a general rule all bookmarks and hyperlinks should have a magnification setting as “Inherit Zoom”. If these important  settings are not correct the document will not pass the eCTD validation rules when you run the eCTD validation software. You will get error reports which can take a long time to correct.

Bookmarks  and eCTD validation rules

Bookmarks are required to facilitate navigation within a file. For example a 10 page file with several subheadings will require bookmarks. On the other hand a 200 page file containing one type of data may not require bookmarks as there are no subheadings to describe the data further.

Generally for files with a table of contents, you should provide bookmarks for each item listed in the table of contents  together with all figures,tables, references, publications, and appendices.

Bookmarks should follow the same order and hierarchy as the table of contents. There should be no additional hierarchy beyond what is in the table of contents. You should however not have more than 4 levels of hierarchy. The bookmarks are essential for the efficient navigation. They

It’s generally expected that PDF files consisting of with more than 10 pages will have bookmarks. However there are exceptions to this rule. The following are excluded from the rule in Canada: literature references in section 3.3, section 4.3, and section 5.4. The life cycle management table as well as the Health Canada application forms is also exempted.

The validation software will also check for incorrect initial view. Documents with bookmarks are expected to  show the bookmarks window in their initial view. Make sure that you set the Magnification and Page Layout  as “default”. If this is not set correctly it will be flagged as an error due to violation of eCTD validation rules.

All eCTDs will include bookmarks as is appropriate. Include only relative bookmarks . They must not not be broken. You should not include non-relative bookmarks. The validation software  will report an error as you will be breaking the ectd validation rules. There are several types of bookmarks that are not allowed. You should have a QC program to check on these bookmarks early to avoid breaking the eCTD validation rules applied by your validation software .

• web link bookmarks
•  e-mail bookmarks
•  external bookmarks
•  inactive bookmarks.
• broken links such as broken inter-application bookmarks,broken intra-application bookmarks and broken intra-sequence bookmarks
• unknown bookmarks

Hypertext links and eCTD validation rules

There is no guarantee that a link to a website, websites or email will remain active over the life cycle of eCTD document. You should therefore not use URL links in your eCTD. You will be breaking the eCTD validation rules and you will find errors associated with affected files.

Most people designate Hypertext links with rectangles according to Health Canada guidance documents . They will use thin lines or blue text to show a Hypertext link. You can improve navigation and efficiency in your document if you use Hypertext links/hyperlinks  to:

• support clarification,
• sections that are related,
• references,
• appendices,
• tables, or
• Figures that are not found on the same page  .

Use relative paths when you are creating hypertext links. If you use absolute hypertext links you will lose the links when you move your work from one storage media to another. Your validation software will record this as an error as you have broken one of the validation rules.

The validation software will check that the destination of the link exists. The link is broken if the destination does not exist or it has been moved or renamed. Always make sure that you are creating the right type of hyperlinks to avoid the pain of having to redo.
If you break the ectd validation rules  due to any of the following  associated with hyperlinks  you will get errors when you run your the eCTD validation software:

•  non-relative hyperlinks
• broken links
•  web links and e-mail links
•  unknown hyperlinks
•  external hyperlinks apart from web links and e-mail links
•  inactive hyperlinks

Its better to create error free documents than to try to correct these errors. Errors can be reduced through training and experience .

If you need training in eCTD you can contact us. We have an online course the may help you especially if you are working full time. We can also help you to prepare a eCTD submission.

Leave a feedback  comment below if you liked this article.

1. Do not include empty folders

An eCTD  folder must contain at lest a sub folder or a file. Folders without at least a sub folder or a file should not be submitted to Health Canada. All the folders are in the sequence folders which is characterized by 4 digits.

2.Remove all file and folder security

Your purpose for submitting a dossier to Health Canada is to get it reviewed. If for any reason the file or folder is protected the review will not take place. A validation software will check in the  sequence folder structure to determine if there are  files or folders in which there are settings that deny the user access .

3.Beware of file size when authoring documents

When you are authoring  documents you must be aware that you have limitations in terms of file size. You must organize your work . You will get a warning if your pdf files are  150-200 MB . These are fairly large files. If you have other files such as data files excluding SAS XPT you will get a warning during validation if the file is larger than 100 MB.

The maximum file size is 200 MB for pdf files and 1GB for SAS XPT . You will get an error if you exceed this limit. Plan your work early so that splitting a file will not turn out to be a burden.

4.Sequence folder requirements

Although people will use eCTD software to file ectd dossiers, failure to understand the rules can cause errors during submission especially in assigning sequence numbers. Remember that the first submission for generic product A must be 0000. The next submission will increase by 1 so that its 0001. Checks the sequence folder name. You will get an error message if Fif the sequence appears  to be initial sequence but its name is not the expected 0000. you will get an error if you mix up sequences such that you you create 0003 before 0002.

5.XML Backbone

The ICH files will be found in the util folder. Some regional files will be found in the m1 folder and util folder. The index file should be in the sequence folder as shown below. If you have wrong files or invalid files in the util folder the validation software will report an error.

6.Review information in Study tagging files

The purpoe of Study Tagging Files (STFs) is to organize clinical and non clinical data in a standardized way that helps  eCTD review. Its equivalent in some way to the index.xml in structure and purpose.

If you have invalid STF files  in the sequence folder they will be reported as errors. A common mistake is failure to QC the metadata . This can limit the value of your STF files.  It is proposed that you have a system in place to QC all the metadata in your STFs.

7.Sequence numbering

As mentioned earlier you should ensure that each successive transaction which you have provided in the life-cycle of the  application, has a sequence number that is sequentially  increased  by 1 number. An example would be 0001,0002,0003,0004,0005 and so on .

You may not skip numbers. To avoid this keep a record of  sequence Numbers that have been allocated for each dossier you submit. If you skip you will receive validation errors. For example if you skip sequence number 4. Validation report for sequence number 5 will report an error.

Conclusion

You may leave a comment below or ask a question.

If you are new to eCTD and would like training contact us . If you would like help in submitting a dossier to Health Canada or to FDA you may also contact us.

If the licence is cancelled or suspended, you are not allowed to sell any product related to that licence.
Before you can apply for a product licence you must know the different pathways for licensing natural health products and the evidence required by Natural and Non-prescription Health Products Directorate to support safety quality and efficacy. The next step is to select the pathway that is suitable for your product. The third step is to assemble the information required in the application.

The product licence application involves filling an application form. This form captures important information based on the regulations. Consultations may be required.

Initially you will be required to provide information about the applicant for the Natural Health Products  licence. You will then be asked to provide your Canadian address and the business name, address and telephone number, and the fax number and e-mail address of the applicant.

If you don’t have a Canadian address, you will be required to find a Canadian representative but you must still provide your own contact information. You will be required to provide the name, address and telephone number, and the fax number and  e-mail address of your representative in Canada

The next most important component of your licence is the medicinal ingredients. It is generally accepted that a natural health product may consist of more than one medicinal ingredient. Certain information about each medicinal ingredient must be provided.

Medicinal  Ingredients and the  Natural Health Products Ingredients Database

For consistency in the product licence application you should provide the proper name and the common name of each medicinal ingredient. These ingredients must exist in the Natural Health Products Ingredients Database. Some ingredients in the database are not Natural Health Products.

You will need to spend some time at the Natural and Non-prescription Health Products Directorate website to determine the proper names and common names as the rules for naming are not uniform.

By the time you are applying for product licence, you already know the dosage form. You should be able to provide the quantity of each medicinal ingredient in each dosage unit such as a tablet or a capsule

If there is a claim for potency on the label, you should provide information about it. You are required to provide potency only if your medicinal ingredient includes standardized preparation. Potency captures the concentration of a medicinal an active or marker constituent of an ingredient.

The source of your medicinal ingredient should be described as this can delay your product licence application review.
You should also provide a statement whether any medicinal ingredient was synthetically manufactured or extracted. This information is required as some potential users may be sensitive to contaminants from its source.

Non medicinal ingredients

Non medicinal ingredients are very important in the manufacture of the dose form. They should be provided in the product licence application. You should provide a qualitative list of the non-medicinal ingredients you propose to be in the Natural Health Products. You should also provide a statement about the purpose of each ingredient. You must ensure that these ingredients are in the Natural Health Products Ingredients Database as your application may be rejected on this account.

Brand Name

To distinguish your Natural Health Products from the others in the market place, you should provide a brand name. This is the name under which you propose to sell the Natural Health Products.

Conditions of  Use must be Carefully Assessed Before You  Apply

Natural Health Products are used for self selection and do not require a prescription. You should therefore provide the conditions which must exist for a person to use that Natural Health product. A product licence for a natural health product to treat diabetes or cancer will be rejected as these are Schedule A diseases. This is one of the areas importers overlook resulting in delays.

Safety and efficacy are a Major Requirement in Product Licence applications

This refers to the information that supports the safety and efficacy of your the natural health product. This evidence may be in form of references, monographs or results from clinical trials. The available information will determine the pathway for submission and the review time.

Provide well prepared labeling information

The purpose of labeling is to inform the buyer r about the origin, cost, quantity, specifications how and how to use the products. This information helps the buyer either to buy or not. You should provide the proper text for each label which you propose to be used along with the Natural Health Products. The label will be reviewed by Natural and Non-prescription Health Products Directorate very carefully. You should therefore take your time and care in preparing the label.

Don’t Prepare Specifications at the last moment

You should also provide a copy of the specifications . These will be the specifications  which the natural health product will be expected to comply with. The attestations attestations described below will also be required. These must be prepared carefully according to the guidance documents.

Who should provide attestations?

Depending on whether the product licence you seek is for imported or non-imported products you will need to provide an attestation. If you are importing the natural health product, you should provide an attestation that the natural health product  manufacturing, packaging, labelling, importation, distribution  and storage is in accordance with the GMP requirements of natural health products or equivalent.

If the natural health product for which you are seeking a product licence is not imported, you also need to provide an attestation that the natural health product  manufacturing, packaging, labelling, distribution and storage are in accordance with GMP requirements of natural health products or equivalent standard.

This summary should help you to get started . If you need help with the application contact us.

1.What Standards should imported products meet?

The regulations place an important the responsibility on the importer of natural health product. The importer is to ensure that any product they brought to Canada meets certain quality standards. These standards d include manufacturing, labeling and packaging from sites that meet the Canadian regulations.

2. How imported natural Health Products should be stored

When natural health products are imported to Canada, they should be stored in premises that comply with natural health products GMP requirements. Such premises should have a site license. The conditions of storage must maintain the quality of the natural health product and subsequently its safety.

3. Appropriate Equipment required

The importer should ensure that the manufacturing, packaging, labeling and storage of any products they import meets natural health products GMP requirements. In addition the equipment used should be designed and constructed to meet and fulfill the required objectives. It should undergo regular maintenance. This equipment should be operated and organized in a manner that, allows effective cleaning of relevant parts, so that it functions in accordance with its intended purpose. The equipment should be constructed to prevent contamination of the natural health product. It should not add any extraneous substance to the natural health product

4. Qualified personnel are needed

It is required that all personnel handling natural health products have appropriate education. The required education may include on-going GMP training or other relevant training. Personnel must have the practical experience which is necessary to carry out their assigned duties. The evidence of education and training must be demonstrated as records in personnel file and updated regularly.
It is the responsibility of the importer to ensure that they import natural health products from companies with evidence that personnel in-charge of manufacturing and quality assurance have the appropriate education, training or relevant practical experience to exercise control and supervise the activities.

5. Practices and procedures that must be in place

Importing from sites that have consistent practices and procedures is easier than sites that don’t have them in place. Importers should import from sites that have practices and procedures in place for material control to ensure quality of material used and quality of the product. They should also ensure the sites have, process control and product recall procedures that are consistent with Natural Health Products GMP requirements

6. Importers to review a supplier’s certificate of analysis

To ensure that imported products meet the required specifications, importers are required to review a supplier’s certificate of analysis. This certificate must be submitted with each lot shipped to Canada. During the review, the importer should verify that all the required testing has been carried out and that specifications are met.

7. Why Stability of NHP is required

I you are an importer stability studies should be performed so that you can determine the period of time that, after packaging for sale, the natural health product will continue to comply with its approved specifications when stored as recommended. If there are no recommended storage conditions the natural health product should be stored at room temperature but this must be supported by stability studies.

8. Samples must be maintained

To meet natural health products GMP requirements, the importer should maintain samples in their final packaging as evidence of product quality. They are important in case an investigation is required due to customer complaint or product recall. These samples should be maintained in an environment that is similar to regular storage conditions in the store to ensure the sample is equivalent to products available for sale.

9. Importers must keep records to comply with Natural Health Products GMP requirements

If you are an importer and of natural health products in Canada you should maintain the following records for natural health products:
• the master production document;
• a list of all medicinal and non-medicinal ingredients contained in each lot or batch;
• records of any testing carried out with respect to a lot or batch;
• a copy of the approved specifications;
• records containing adequate information to permit the recall of every lot or batch made available for sale and a
• copy of the sanitation plan in use by the importer.

10. Importers must maintain recall procedures

The importer must maintain a recall system and recall reporting to implement a product recall successfully. This ensures that all the relevant information is accessible and all the natural health products presented for sale are correctly presented to the public.

Others such as acetaminophen treat common disease such as pain.  Not all diseases have an equivalent generic pharmaceutical. Generic drugs are cheaper than the original brand name drugs.

Many consumers feel relieved when a generic drug comes into the market. They can get a price reduction sometimes up to 80%.

Most people are not aware of the generic version until they are alerted by their family doctors or pharmacists.
In some cases a person may have to wait for a long time to see a generic in the market because of patent protection.

For example in 2015, the FDA approved over 40 new innovative drugs. Its not easy to predict when generic drugs will be available in the market.

In December 2015 the public was surprised and upset to read in the press of the generic pharmaceuticals review delays. About t 4,300 generic drugs were waiting for approval.

The question most people were asking was, Why the delay?
To answer this question we have to understand what happens when a pharmaceutical company submits an application to the FDA for approval. Different companies made different errors of omission.

Patent problems and delays of reviews: generic pharmaceuticals

Patents are very important for generic drug companies as well as innovator companies.  Without a patent or reference to an expired patent, a pharmaceutical company will not get a dug approved for marketing.

If a pharmaceutical company lacks this knowledge, it would appear to be in the wrong business. It must have personnel who will be able to notice this deficiency very early.

The FDA will not approve a generic drug to be marketed if the referenced patent is being contested in court. Faults in patent information are common causes of generic pharmaceuticals review. We can organize an in house course to help your company. Contact us. Your staff can also take an appropriate online course.

Evidence that the generic had passed the test

The generic drug must be tested where possible in healthy people to proof that it’s a therapeutic equivalence to the brand name drug.

After the test, data is evaluated by pharmacologists and other experts to ensure that it meets all the regulatory requirements.

Failure to provide relevant data of high quality results in the rejection of the application or a delay of the review. This is a common cause of generic pharmaceuticals review. Some companies may take this process lightly only to be shocked when the application is rejected.

Quality of the generic

The development of the generic drug must demonstrate high standards of the formulation. Regulators want to see Quality by Design (QbD) approach.

Regulators now want to see QbD  in developing a generic drug product formulation. This is expected to provide evidence for a rational formulation and manufacturing process which should ensure the, safety, efficacy and quality of the product.

A deficiency in providing appropriate quality information to the regulatory agencies is another common cause for delays in the review of generic pharmaceuticals.

The breakthrough  treatment status is designed to help shorten the development time of a potential new therapy.
A breakthrough treatment has all the characteristics of a fast track drug plus other requirements.

FDA involvements are increased as shown below. This process is designed to decrease the development and review period for quick availability of the drug to potential users. It requires involvement of the senior managers of the sponsor and it provides opportunities for the sponsor to request rolling reviews and priority reviews.

Breakthrough treatment involves cooperation of the sponsor with the FDA

The following is required:
•Arranged meetings where the sponsor and the FDA review team can meet to resolve issues as the drug is developed.
•Sponsor to obtain timely advice from thorough interactive communication relating to drug development to ensure that the development program is well thought out and planned for the collection of the nonclinical and clinical data required for the drug approval. The FDA may assign a a breakthrough status to a drug, but this status can be withdrawn if on further investigation a lack of significant benefit to the patient is observed.
•The sponsor also takes steps to ensure that the clinical trials designs are efficient so that fewer patients are exposed to a drug of unknown efficacy.
•FDA to assign a cross-disciplinary project person for FDA reviews team who facilitates an efficient review. This team will review the development program. It also serves as a scientific liaison between the cross-discipline review team members for coordinated internal interactions and communications with the sponsor through the Regulatory Health Project Manager in the review division.
•involving senior officials at the manager level and experienced review staff, as appropriate, in a joint cross-disciplinary review
Ten of the 2015 novel drugs had clinical evidence demonstrating that the use of these drugs may result in considerable improvement on at least one clinically significant endpoint over other available treatments .They were therefore approved by the FDA were based on break through therapy designation. The drugs , approved indication and the name of the manufacturer are listed below. Doctors can now prescribe these products to some of the very needy patients.

It is possible for a drug to be designated more than one  status. Of the above 2015 approved drugs under fast track status five of them were classified as breakthrough drugs. These are Kanuma, orkambi, strensiq, Tagrisso and Darzalex. Proper classification is very important for better and timely review. Many brand name companies are aware of the risks of rejection of a NDA and employ highly qualified regulatory affairs personnel or consultants.

How FDA fast track designation helps to speed up drug development

A process is  followed to determine if  a drug merits FDA first track designation. First the sponsor must submit a request for FDA  fast track designation or just fast track to the FDA. The request must include the supporting documents and the  proposed use. The FDA is required by the statutes to accept or reject the request. The advantages of FDA fast track designation include review of parts of the NDA before the complete application is ready, increased communication through allocation of resources, shortened review time.

The fist track designation strategy is based on the FDA Modernization Act of 1997. This strategy allows drugs which met a two main criteria to be designated fast track drugs. Firstly the drug must be for the treatment of a serious or life-threatening condition. Secondly the drug has to address a medical need which has not been addressed before.

If the Fast Track designation is approved by the FDA, the sponsor is encouraged to meet with the agency for discussion about the development plans. These discussions are useful if initiated early before the sponsor submits a NDA/BLA. Early consultations may help to clarify certain elements of the clinical trial designs and the presentations. The consultation meetings are useful as they help to resolve issues that could delay approval of the NDA/BLA.

FDA consultation meetings can be requested by any sponsor who requires FDA inputs during the process of drug development. However there is a unique opportunity within FDA Fast Track designation which allows the sponsor to submit sections of an NDA/BLA as they are completed. This option is not available for sponsors submitting the standard NDA/BLA. These sponsors submit a complete application to the FDA at once.

Of the FDA approved novel drugs in 2015, fourteen drugs (31%) Had FDA fast track designation. These drugs were approved because they had a potential to meet a need that had not been met before.

The following drugs  approved in 2015  had FDA fast track designation

From this list its apparent that FDA fast track designation can be used for any new drug fits the criteria. Some of the drugs approved are biologics, pharmaceuticals which include antibiotics.

Who needs Good clinical practice training

All the personnel involved in any way during the conduct of clinical trials require GCP training. The purpose of the training is to ensure that the personnel will be able to carry out duties related to the clinical research effectively while protecting the welfare of the study participants. Things that might appear insignificant to the personnel may have significant impact on the study outcome of a clinical study. Good clinical practice training is an important requirement; personnel must also have some experience in the field of work.

Good clinical practice training frequency

GCP training frequency is variable. Each clinical research protocol has different requirements relating to GCP training. It’s therefore not easy to say how often a person will need GCP training.
After the initial detailed Good clinical practice training, subsequent trainings should not be in as much detail as the initial training. They should be updates in regulations, guidelines, new software, safety and specific applications to the protocol. These trainings may last for a day or a few years. Some people miss the initial detailed Good clinical practice training and begin with the updates. These people tend to face certain challenges which are difficult to overcome

Online Good clinical practice training

Our online courses are results oriented. They help participants gain essential knowledge and practical skills that are relevant to clinical research. Participants also learn to appreciate behavior or attitudes that can compromise the outcome of a clinical study. Our courses focus on the site staff playing different roles in the conduct of clinical trials. If you would like more information please contact us.

We provide initial detailed Good clinical practice training and subsequent GCP updates.

Contact us now