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Bethesda North Marriott Hotel and Conference Center

2014 年 04 月 09 日 7:00 上午 - 2014 年 04 月 10 日 5:45 下午

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Labeling 2014: Compliance in a Changing Regulatory Environment

Session Chair(s)

A. Leander  Fontaine, MD

A. Leander Fontaine, MD

President

Pharmiceutics, LLC., United States

Speaker(s)

Joseph  McMillian

Panelist

Joseph McMillian

Heartland Compliance Services LLC, United States

Principal Partner

Ralf  Zerban, DrMed

Panelist

Ralf Zerban, DrMed

Vigiserv GmbH, Germany

Managing Director

Barbara  Lachmann, MD

Panelist

Barbara Lachmann, MD

Barbara Lachmann Labeling Consulting, Germany

Sole Proprietor

Julie P.  Retzinger, MBA, RN

Panelist

Julie P. Retzinger, MBA, RN

Astellas Pharma Inc., United States

Senior Director - Global Labeling and CCDS

Gerrit  Nijveldt, MS, MSC

Panelist

Gerrit Nijveldt, MS, MSC

Opus Regulatory, United States

Global Labeling Consultant

Rie  Matsui, RPH

Panelist

Rie Matsui, RPH

Pfizer R&D Japan G.K., Japan

Senior Director, Regional Labeling Head for APAC

Megann  Looker

Panelist

Megann Looker

Jazz Pharmaceuticals, United Kingdom

Executive Director, Head of Global Labeling

Su-Yueh  Lin

Panelist

Su-Yueh Lin

SYL Regulatory Consulting, Taiwan

Sr. Labeling Consultant, Regulatory Affairs

Takashi  Misu, PHD

Panelist

Takashi Misu, PHD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Principal Coordinator, Office of International Strategy and Planning

Bruce  Boulton, MSC

Panelist

Bruce Boulton, MSC

Health Canada, Canada

Product Information Officer, Bureau Gastroenterology, Infection & Viral Diseases

Anna  Toth, PHARMD, MSC

Panelist

Anna Toth, PHARMD, MSC

Medical Products Agency, Sweden

Pharmacovigilance Inspector, Drug Inspectorate Industry & Hospital

Mark  Collins, PHD, MBA

Mark Collins, PHD, MBA

Opus Regulatory, United States

Principal Consultant

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