CRED Generics: Understanding the Regulatory Considerations

Generics: Understanding the Regulatory Considerations Wednesday 11 October 2017, TOPRA Office, London Programme Chairperson: Natalie Beasley

Time 09.00 09.30




Welcome and Introduction to TOPRA

Samantha Alsbury TOPRA Natalie Beasley Concordia


Introduction to Course


Introduction to Generic Medicines What is a generic? The legislation •

Sue Harris MHRA

Legal Basis of Generic Applications

Application types

10.45 11.05

Tea and coffee break

European Procedures for Generics • Centralised Procedure • National, MRP and DCP • Referrals Bioequivalence studies and Biowaivers • CHMP Bioequivalence Guidance • Design of studies • Evaluation of data • Biowaivers for new submission and variations • New EMA guidance

Francesca Buttigieg Diamond Biopharma Limited


Jon Sisson MHRA

13.00 14.00


Generic medicines: a regulator’s perspective • Potential pitfalls and practical issues experienced with regulatory strategies and dossiers for generic medicines • An agency perspective on common findings arising during regulatory review o Current experience and advice on preparation of the dossier for a generic medicine. Specific considerations for: o Administrative data (Module 1)

Sue Harris MHRA

o Summaries and Overviews (Module 2) o Chemistry and Pharmacy (Module 3)

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