Event: International Pharma Regulatory Summit

Dates: July 27 – 28, 2017

Venue: TBD, Singapore

Weblink: www.wplgroup.com/aci/event/pharma-regulatory-asia

Contact: Priyesh Waghmare

Tel: +91 (0) 20 6527 2803

Email: pwaghmare@acieu.net 

Asia's regulatory systems are diverse, and oftentimes challenging to navigate. The regulatory agency in each Asian country has its own set of regulations and customary manner of conducting business. Thus, determining the most effective and efficient strategy to obtain approval for your pharmaceutical product from each regulatory body without sufficient knowledge and experience with Asian regulatory affairs can be a very difficult task.

Against this backdrop, ACI brings you International Pharma Regulatory Summit 2017 will enable you to make confident, actionable decisions.

Highlighted features at 2-day conference includes:

• Regulatory submissions implementation in eCTD format
• The ASEAN Labelling Harmonisation Effort
• Registration and approval timeline – combination products and exemptions
• What's new with clinical regulatory requirements in Asia Pacific?
• Global trends vs. specific region’s updates for pharmacovigilance
• Regulatory affairs support in providing advices to commercial team for inspection
• Global Guidelines for the Development of Biologics