Finny Liu is the APAC Regional Regulatory Policy Lead, Product Development Regulatory, at Roche based in Singapore, responsible for leading regional Regulatory Policy activities, developing and executing a regional policy roadmap and associated Roche positions to drive global regulatory convergence in APAC. Previously, she was the Head of APAC International Operations at Roche located in Singapore responsible for Asia Pacific regional management of life-cycle submissions for Roche products to ensure right first-time submissions to Health Authorities during Aug. 2013 to Jun. 2016. She holds a Master Degree in Pharmaceutical Technology and a Bachelor Degree in Pharmacy, both from the National Taiwan University, Medical College.

Dr Viraj Suvarna is President Medical at Eris Lifesciences Limited, and serves as independent consultant and expert in medical affairs in India. He has previously served in various Medical Operations functions at Boehringer Ingelheim, Pfizer, and Plethico Pharmaceuticals Ltd. He has also served on the faculty for DIA India’s Crafting Sound Medical Affairs Professionals 2018 workshop.

Dr. Venugopal G Somani is the Drugs Controller General of India (DCGI) since July 2019. Dr. V.G. Somani did his MPharm and PhD in Pharmaceutical Sciences from Nagpur University, India. Earlier he worked as a Joint Drugs Controller (India) in CDSCO heading the Divisions of Regulation of Medical Devices & In vitro Diagnostics, Stem cells & Blood Products, New Drugs (which are Subsequent & Fixed Dose Combination), He has also worked as Joint Drugs Controller (India) heading the divisions of Biologicals, Clinical Trial, New Drugs and Cosmetics, Enforcements for several years. He was primarily involved in dossier assessment, monitoring, and framing of proposals for amendments in Rules, policies, and guidelines.

Dr. Sundar Ramanan’s expertise is in biologics manufacturing, process development and global regulatory affairs. He currently serves as the technical & scientific policy lead in the Global R&D Policy team at Amgen.

Dr Saint-Raymond is a French paediatrician. In 1995, she joined the French Medicines Agency, and in 2000 she joined the EMA where she was the Head of Special Areas (Paediatrics, Orphan Drugs, Scientific Advice, SME Office and Scientific Projects). She implemented the European Orphan Drug Regulation then the Paediatric Regulation. She has been an expert for the European Commission, the European Developing Countries Trial Partnership, the Canadian Council of Academies, and the US National Academies of Science, Engineering and Medicine, a member of the UN Commission on Life-Saving Commodities for women and Children and Associate Prof of Paediatrics at Tor Vergata University Rome.

Pär Tellner is Director EFPIA since 2012 and member of ICH Management Committee and Assembly since 2016. Pär has previously been working as Compliance officer (marketing ethics) and Director of Veterinary Medicine, LIF Sweden and as Head of regulatory affairs for several pharmaceutical companies, e.g Octapharma, Biovitrum, Pharmacia Plasma Products and Novartis. Pär has also been working as Senior Pharm. Officer for the Swedish Medical Products Agency. Pär graduated as a pharmacist at Uppsala university in 1986.

Mike Ward is Coordinator of the Regulatory System Strengthening Team, Department of Essential Medicines and Health Technologies, Health Systems and Innovation Cluster, WHO Headquarters; he joined WHO as the Coordinator, Prequalification Team, in this same Department. He previously worked within Health Canada as GMP specialist, drug evaluator and manager, international policy analyst, and Manager of the International Programs Division of the Therapeutic Products Directorate. Mr Ward served on many international harmonization steering committees and helped to launch the APEC Regulatory Harmonization Steering Committee, the International Generic Drug Regulators Pilot, and the International Medical Device Regulators Forum.

Ramakrishnan (Ram) Sundaram serves as India Regional Director of Regulatory Affairs, Established Pharmaceuticals Division, for Abbott. He previously served as Director of Regulatory Affairs for both Bristol-Myers Squibb India and Dr. Reddy’s Labs. Mr. Sundaram also served in various roles in regulatory affairs and biologics process development in the US for such companies as Bristol Myers Squibb, ImClone Systems (Eli Lilly), and Millennium Pharmaceuticals (Takeda Oncology), before moving to India for his assignment with Dr. Reddy’s. He received his undergraduate and post-graduate education in the US and in India, and earned his Quality Assurance/Regulatory Affairs certificate from Temple University.

Kum Cheun (KC) is Head of Asia Pacific Regulatory & Development Policy for Novartis, leads in the development of regulatory and development policy, and regulatory intelligence for Asia Pacific. He is Co-Chair of Singapore Association of Pharmaceutical Industries (SAPI) Regulatory Affairs Committee, Chair of EFPIA ASEAN Regulatory Network, ASEAN Pharmaceutical Research Industry Association (APRIA) and active member of EFPIA International Regulatory Expert Group (IREG), EFPIA regional regulatory networks (India, Korea-Taiwan), DIA Steering Committee of Singapore, DIA Asia Labelling Community member, ISPE Asia Pacific Focus Group, Steering Committee of APAC, member of APAC RA-EWG, member of APACRM and CoRE Duke-NUS Visiting Expert.

Thean Soo Lo is a Regulatory Affairs Management Consultant specializing in the design and development of a robust, efficient, forward looking regulatory department within the organization to provide optimal support to the business, through optimal and expeditious product registration and product license maintenance within the organization. Thean Soo Lo is a pharmacist by training, with a B. Pharmacy (Hons) degree, and a MSc degree on comparative analytical methodology and pharmacokinetics of drugs in biological fluids. Prior to his current role, Thean Soo Lo had prior experience as the AP Lead for regulatory policy & intelligence, and AP Regulatory Affairs Head in Janssen Pharmaceuticals, J&J.