This brand new course, hosted by experts from the
TOPRA Biotech Special Interest Network, will discuss the key guidelines,
phase-appropriate requirements, getting the right level of detail in
the biotech IMPD and examples of what are classed as substantial and
non-substantial amendments.
With the emphasis on the interactive aspect of the
CRED courses, enabling you to immediately put theory into practice, this
workshop allows you to get to grips with building a successful biotech
IMPD. Delegates are invited to bring questions to facilitate discussion
in all of the key sessions. This course is essential for anyone who
requires comprehensive information on this subject; whether you are new
to biotech or simply wish to update your knowledge. If you are working
on submissions on a regular basis and want to discuss the challenges
they face with others, you should attend this course.
An Investigational Medicinal Product Dossier (IMPD) is required as part of the Clinical Trial Application for every Investigational Medicinal Product (IMP) and non-investigational Medicinal Product (nIMP) used in a clinical study.
The IMPD includes summaries of information related to the biological, chemical and pharmaceutical quality of the IMP containing biological/ biotechnology derived substances as described in the EMA ‘Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials’ (CHMP/BWP/534898/2008). The scope of the course is the quality documentation for the IMPD for biotech products; nonclinical and clinical aspects of the IMPD are outside the scope.
Draft programme (download 150KB)
For more information please download the course flyer (download 526 KB)
Speakers:
-
Julie Foulkes, Freelance Regulatory Affairs Advisor, UK
- Mairead Duke, Consultant, UK
- Paul Jeffreys, Associate Director, Eisai Ltd, UK
- Stephen Fitzpatrick, Senior Director, Genzyme, UK
- Sharon Longhurst, Principle Consultant, Parexel, UK
- Catherine Bentley, Tandem Regulatory Services, UK
CPD
This course offers 5 CPD hours for successful completion
Why is Continuous Professional Development important?
As a professional in regulatory affairs you have a personal responsibility to maintain your level of knowledge and competence; you are therefore encouraged to participate in Continuous Professional Development.
CPD is important to you as;
- It demonstrates to your employer that you have planned, updated and maintained your knowledge and experience.
- It enables you to develop your knowledge and experience for your present role and any potential future roles.
To register, please log in or create an account
Course price (including VAT):
Member: £660
Non-member: £810
Those working for regulatory agencies or government agencies or academic institutions:
Member: £495
Non Member: £607.50
For the 25% discount please contact meetings@topra.org for the code
Those working for charities, patient groups or in full time education:
Member: £165
Non Member: £202.50
For the 75% discount please contact meetings@topra.org for the code
Please note the number of discounted places may be limited.
All fees are shown in Pounds Sterling and include VAT
- Fee excludes accommodation and travel. The delegate ticket includes refreshments at coffee breaks and buffet lunches (if applicable).
- All cancellations must be received in writing 28 calendar days before the start of the course and will be subject to an administration fee of £100 + GB VAT. We regret that registrations cannot be transferred to another course, however delegate substitutions may be made up to 10 working days before the course.