Learning Tracks

Post-approval changes are subject to various regulatory requirements and discussed in guidance. SUPAC guidances provide specific examples of reporting categories for the classes of drugs they cover (e.g., SUPAC- IR, SUPAC-MR, SUPAC-SS). Some classes of drugs are not covered by the SUPACs (e.g., transdermal products). Complex generics, including drug-device combination products, are currently not addressed in guidance. This session will include discussion of ideas for facilitating management and assessment of post-approval changes, including the pros and cons of using the lifecycle management approach in ICH Q12.

Participants:
Umesh Pai, M.Pharm. 
AVP, MSTG, Regulatory & Business Continuity, Sun Pharmacueticals

Tian Ma, PhD (invited)
Bioequivalence Reviewer, Office of Bioequivalence, OGD, CDER, FDA

Niles Ron, PhD (invited)
Supervisory Pharmaceutical Scientist, Office of Product Quality Assessment II (OPQA II), OPQ, CDER, FDA

Gina Sirianni, M.Sc.
Senior Director, Complex and Biosimilars, Apotex Inc.

Moderator: Anand Saxena, M.Sc.
Director, Regulatory Affairs, Cipla