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Life-Cycle Management and CMC dossier
Session Chair(s)
Sofia Ribeiro, PHD
Head Regulatory Affairs CMC, Bayer US LLC, United States
This session will focus on the regulatory framework for product Life-cycle Management. In particular, the participants will discuss the impact of the new ICH M4Q (R2) and the guidelines developed by the Expert Working Group; the new EU variation guideline and the opportunity for pragmatic approaches to PAC (Post Approval Changes) and the implementation of PAC using ICH Q12 principles, harmonization of regulatory requirements and the use of reliance to enable accelerated implementation of changes globally. Key stakeholders including regulators, industry and patients are invited to discuss the impact of the current and new regulatory legislation on PACs.
Learning Objective : Provide a background explaining how delays in implementation of PACs can cause constraints to supply o medicines to patients Provide suggested solutions to create a global process for implementation of changes
Speaker(s)
Mic McGoldrick, MT
CMC Technical Advocacy and Policy, MSD, United States
How Product Supply is Impacted by Delayed Implementation of PACs
Khushboo Sharma, MBA
Chief Executive Officer, Accumulus Synergy, United States
Collaborating as an industry towards a single digital global dossier
Henrik K. Nielsen, PHD, MBA, MSC
Vice President, Novo Nordisk A/S, Denmark
ICH M4Q(R2) – a new paradigm for the CMC dossier
Agnes Dangy-Caye, DRSC
Regulatory Science & Policy Manager, Sanofi, France
Revision of the EU variation guideline: Expectations and further needs for a more pragmatic approach in patient’s interest.
Veronika Jekerle, PHD, RPH
Head of Pharmaceutical Quality, European Medicines Agency, Netherlands
Panelist
Hamadi Gamal
, Belgium
Panelist
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