This course will explore the key regulatory requirements associated with generics medicines. You will gain a full understanding of regulatory strategy and data requirements for Abridged Applications.
On completion of this course you will gain
- An understanding of how generic medicines differ from proprietary medicines from a regulatory perspective
- An understanding of the legislation relating to Abridged Applications
- An understanding of the specific regulatory considerations for chemistry, manufacturing and controls (CMC)
- An appreciation of the specific regulatory considerations for bioequivalence studies
- An understanding of generic medicines from the regulator’s perspective
Speakers include experts from the generics industry and from regulatory agencies
Includes a practical case studies to embed the learnings.
Download the programme (subject to change)
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Registration fees
Member: £660.00
Non-member: £810.00
- Personnel in full-time education, working in academia (full-time) or working for a statutory regulatory body may be entitled to a discount on the above fees. Please contact the TOPRA office for details.
- 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.
All fees are shown in Pounds Sterling and include VAT (where applicable)