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Track 1 Session 3: Challenges and Opportunities in Generics
Session Chair(s)
Sonica Sachdeva Batra, MD
Associate Vice President Enterprise Medical;Global Head- Regulatory Affairs, Indegene Ltd., India
Generic companies frequently face challenges on signal management, which may impact updates to product information related to safety concerns especially when these originate externally. Competent authorities’ expectations are similar for innovative and generic marketing authorization holders in respect to the signal management and label changes. Based on the regulations and information received from the authorities “sufficient evidence” is needed for safety variations for generics, as well as for the innovative products. However, in practice signals submitted by the generic MAH many a times face rejection or are placed on hold on the grounds of “insufficient evidence”, in particular when the reference product label doesn’t include the respective safety topic.
Speaker(s)
Generic Label Management
Global Head – CHC, Consumer Healthcare Division, Sanofi, United States
Generics MAHs: Challenges in Managing Signals and Labelling Changes
Multi Country Safety Head – South Asia & Indo-China (Vietnam), Sanofi, India
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