Executive Roundtable: How the PMDA and New Regulations Impact Operations

Join senior clinical operations and regulatory professionals at this exclusive roundtable discussion held over lunch on June 14. This special forum will be lead by Haig Oghigian, Senior Counsel, Squire Patton Boggs and Reed Maurer. Both speakers have extensive experience in the pharmaceutical and life sciences sectors and are held in extremely high regard. They will provide their essential insights to help your organization employ efficient and accurate strategies to mitigate legal & compliance risks in the context of a rapidly changing legal environment.

Topics include:

• Updates on the recent Clinical Research Act- (published April 2017)
• GCP (Good Clinical Practice) Amendments
• Expansion of conditional approval by PMDA

The Speakers

Haig Oghigian, Senior Counsel
Squire Patton Boggs

Haig Oghigian has extensive corporate experience in the pharmaceutical and life sciences sectors and has advised on matters related to M&A, joint ventures, license and distribution agreements as well as market entry compliance and regulatory issues. A former Canadian diplomat in Japan, Haig also assists clients with regulatory and government relations matters, working closely with Squire Patton Boggs Public Policy Practice.

Haig has acted as counsel, arbitrator and/or mediator in more than 100 cases, including high profile ICC, JCAA and SIAC cases in Asia, Europe & USA. He has also represented an industry association in a nontariff trade barrier dispute against the Japanese government at WTO. Haig is consistently highly ranked by leading rating institutions including Chambers, GAR & Asia Law 500. He is widely published in various journals and is author and editor of The Law of Commerce in Japan (Prentice Hall). He is admired for his understanding of Japanese culture and excellent interpersonal skills, as well as his strong track record in international arbitrations and mediation.

Haig is listed as an arbitrator and mediator with Japan Commercial Arbitration Association (JCAA), International Chamber of Commerce (ICC), International Centre for Dispute Resolution of American Arbitration Association (AAA), Singapore International Arbitration Association (SIAC), British Columbia International Commercial Arbitration Association (BCICAC), World Intellectual Property Organization (WIPO), Beijing Arbitration Association (BAA), London Court of International Arbitration (LCIA) and Kuala Lumpur Arbitration Centre (KLAC).

P. Reed Maurer

Reed is a well-known figure among pharmaceutical companies in the Japanese market and has a long and distinguished history in the pharmaceutical industry, having lived and worked in Japan since 1970. Reed was the first Japan Representative of the US Pharmaceutical Manufacturers Association (1987-1993). He is the founder of the Hawaii based company IAL (USA) LLC., and International Alliance Ltd in Japan. In 2009, Reed became a Director of Teva- Kowa Pharma Co Ltd, serving until 2011.

He has also been VP of Eli Lilly Japan K.K. and subsequently VP of Merck & Co- during which time he directed the purchases of a majority interest in Banyu Pharmaceutical Co. and Torii Pharmaceutical. Reed has authored many professional articles such as “Restructuring in the Japanese Pharma Industry“ and books including: “Competing in Japan”; “It’s Worth Doing: Perspectives on the Japan Pharmaceutical Industry”- a must read for anyone engaged in cross-border dealings with Japan in the pharmaceutical industry. Reed currently also leads a forum of pharma company presidents. He has served as Associate Professor of embryology and genetics in Bucknell University and received MS (Biology) in Biology from Pennsylvania University in 1962.

Who should attend this event:

• Head of Procurement
• Global Clinical Study Manager
• Senior Director, Clinical Development Operations
• Head Clinical Operations
• Senior Regulatory Affairs Managers
• Director, Clinical Operation
• Head of Strategy and Operations
• Chief Operating Officers
• Country and Clinical Operations Director

This executive roundtable is sponsored by Lionbridge, one of the world’s largest providers of translation and languages services for the life sciences industry.