With a 9-year track record of successfully bringing to market the latest developments and insights from decision makers, the Pharma Regulatory Affairs Summit remains the only such conference in Asia. Part of the PharmaCon suite of events, the conference affords you the opportunity of getting hot of the press information and networking across various pharma industry segments.

“Many interesting topics were presented in the conference. Met regulatory affairs from various companies across Asia and exchanged information regarding issues we have faced in registering the product.”
Astuti Kurniati, Associate Principal Regulatory Specialist, PT Dexa Medical

Conference Highlights:

  • Regional Government updates on initiatives, reducing backlogs, new guidelines
  • Drug approval bottlenecks - And how to work with regulators to optimise timelines
  • Pharmacovigilance Regulations - REMS vs RMP, PSUR Submissions, and other updates
  • Product Registration, Submission & Approval - Masterclass focusing on the region
  • Supply Chain, Labelling and Distribution  - Standards and compliance strategies required
  • Country Case Studies  - From Pharma on interpreting and working with specific country requirements

Featured Speakers

Datin Dr. Faridah Aryani binti Md Yusof
Deputy Director Centre of Product Registration, National Pharmaceutical Regulatory Agency, Malaysia

Shanti Marlina Sibuea
GMP Inspector, National Agency of Drug and Food Control (NADFC) Indonesia

Senior Representative
Taiwan Food And Drug Administration, Taiwan    

Dr. Silke Nolkemper
Director Consulting APAC (Regulatory Affairs), EXTEDO, Germany

Vicky HAN
Senior Director, Regulatory Policy Group Lead for Asia Pacific, GRA, Jansen Pharma Singapore

San San Win
Regulatory Affairs Manager, Sanofi Myanmar Co., Ltd

Rakesh Chaurasia
Head-Regulatory Affairs, PT. DEXA-MEDICA, Indonesia

Dr. Akshaya S. Odak
Head - Regulatory (Biotech), LUPIN LIMITED, India

Dr. Merricc Edgar-Hughes
Senior Manager, Regulatory Affairs and Pharmacovigilance, Eli Lilly & Company, Australia

Simon Fisher
Chief Scientific Officer, Novartis ANZ, Australia

Part of


Co-Located Events

Past Audience Reviews

“Good networking opportunities with amazing people in the industry. This is my first conference and looking forward for more.”

Nur Farhana Muhamad
, Market Analyst, Pharmaniaga Berhad

“Many interesting topics were presented in the conference. Met regulatory affairs from various companies across Asia and exchanged information regarding issues we have faced in registering the product.”

Astuti Kurniati
, Associate Principal Regulatory Specialist, PT Dexa Medica

“This was a fantastic gathering and a very well organized event. Would love to attend this in the future. Keep up the good work”

Rahul Mongia
, Research Associate, ICRIER

“High quality speakers - Strategic inputs valuable for my day today”

Astrazeneca

“Very interactive with case based learning approaches”

Abbott Healthcare

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