- The 3rd Pharmaceutical Regulatory Affairs Summit Asia will bring together TOP Regulatory Affairs Executives coming from Global Pharmas and leading Biotechs to discuss central issues on Regulations in ASEAN with updates on Harmonization and spotlight on Clinical Trials, Biologics/Biosimilars and Marketing.
Take full advantage of practical learning and detailed how-to’s during the interactive workshops:
Obtain a comprehensive understanding of recent changes in the application process to facilitate successful FDA approval applications for biosimilars and follow-on branded generics. Understand key insights into regulatory requirements and processes for US FDA approval of drugs and biologics.
Led by: Dr Duu-Gong Wu, Executive Director, Consulting Division, PharmaNet Development Group International (PDGI), USA and former US FDA Deputy Division Director
- Post-Conference Workshops
(B) Understanding Regulatory Affairs for GMP & Manufacturing
Get in depth understanding of the regulatory issues and concerns. You will discover insights in how regulatory knowledge can help manufacturing functions to continually improve, qualify for the GMP accreditations and foster communication among industry and regulatory authorities.
Led by: Dr. Shivraj Dasari, Vice President – Quality Management & Regulatory Affairs, InnoBio Ventures Sdn.Bhd, Malaysia
(C) Regulatory Affairs for Generics Companies
Learn useful insights into the generics regulatory framework. Discussions include the scope of the regulatory profession and the role and responsibilities of the regulatory professional. This session is designed to provide an understanding of the regulatory environment of generics companies.
Led by: Zoher Sihorwala, Vice President – Global Regulatory Affairs, Dr. Reddy’s Laboratories Ltd., India
Testimonials from past attendees:
“It was interactive, speaker well prepared” - Sanofi Aventis -
“Excellent topics and speakers”
- Novartis -
“Informative. Learnt about how other countries work & the difference in expectations” - KK Women and Children’s Hospital -