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Challenges in Managing Global Regulatory Divergence
Session Chair(s)
Thomas W. Schultz, PhD, MS
Senior Director, Regulatory Sciences, Global CMC Regulatory Affairs
Janssen Pharmaceuticals, Inc. , United States
Multinational pharmaceutical companies generally manufacture the same product, the same way for every market, region and patient around the world. However, in the emerging markets, divergent, nonscientific, regulatory standards are proliferating. Increased global divergence in regulatory requirements and review times unnecessarily increase manufacturing costs, complicates the supply chain, hinders science and risk-based approaches, increases collective regulatory burden, reduces continuous improvement and innovation and delays delivery of medicines to patients. This forum will include specific examples highlighting instances where the lack of global harmonization results not only in present day challenges but potential opportunities for future convergence.
Learning Objective : Identify the variety of regulatory criteria; Explain the reasons for increasing global regulatory divergence; Describe the impact of global regulatory divergence to the patient, individual regulatory authorities and the industry.
Speaker(s)
International Cooperation in the Pharmaceutical Supply Chain
Emer Cooke, MBA, MSc
European Medicines Agency, Netherlands
Chair, ICMRA; Executive Director
Substandard, Falsified and Counterfeit Drugs
Howard Sklamberg, JD, MA
Arnold & Porter, United States
Partner, Life Sciences and Healthcare Regulatory
Export Dossiers: Global CMC Submissions That Do Not Compromise Proprietary Information
Peter Lassoff, PharmD, RPh
Syneos Health, United Kingdom
Senior Vice President, Head of Regulatory, Medical Writing and Regulatory Intell