Elliott T. Berger, PhD, is President of ETB Regulatory Consulting, LLC. He recently retired from BioCryst Pharmaceuticals, Inc., where he held the position of Senior Vice President of Regulatory Affairs for 14 years. He has frequently served as speaker and session chair at numerous meetings and workshops for DIA and for the Pharmaceutical Research & Manufacturers of America (PhRMA). He serves as an instructor for the DIA Regulatory Affairs: The IND, NDA, and Post-Marketing training course and is a member of the DIA Regulatory Training Committee.

Ms Carol H. Danielson, Dr PH, RAC has provided regulatory expertise and leadership for more than twenty five years for drugs, biologics and medical devices from discovery through post-marketing. Her areas of specialization include regulatory strategy and submissions, clinical affairs and compliance, and quality assurance and control. Her background includes both extensive “hands on” experience and corporate level strategy activities from partnering due diligence to serving as an expert witness in the drug development process.

Dr. Scott has more than 30 years of experience in drug regulatory affairs in the pharmaceutical industry, and is currently at Sobi, a specialty pharmaceutical company that is building a portfolio of differentiated medicines for patients with rare conditions. She has served in a number of companies, including BDSI, Cempra, EMD, Pfizer and Parke-Davis, as a principal in constructing clinical regulatory strategies and submissions for the development of products across a range of therapeutic areas, with a focus on anti-infective drugs. She is also a certified paralegal with primary interests in administrative law and intellectual property.

Mr. Masayoshi Higuchi is a vice president and the head of Quality & Regulatory Compliance Unit at Chugai Pharmaceutical Co Ltd. He has over 30 years of experiences; including 2 years’ regulatory works at Roche in Basel, Switzerland. His areas of specialization include small molecular, biologics and medical devices from discovery, development, manufacturing, and to post-marketing. He was a member of the Japan Pharmaceutical Manufacturers Association (JPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Federation of Pharmaceutical Manufacturers' Associations of JAPAN, FPMAJ and other industrial associations during his career.He has also contributed to Drug Information Association (DIA) since 2014.

Japan Regulatory Portfolio Lead, Regulatory Strategy Group 3, Regulatory Strategy & Policy, Regulatory Affairs, Pfizer Japan Inc. Biography: I have worked for Pfizer since 2003. As a Japan Regulatory Lead, I worked on drug development (NDA/ PMDA consultation). I currently work on development drugs in Inflammation, Pain, CNS and Endocrinology as a Japan Regulatory Portfolio Lead. I received my bachelor and master degree in Pharmaceutical Science from Fukuoka University.

Mr. Matsuoka is Senior Director of Pharmacovigulance Department at Daiichi Sankyo Co., LTD. He joined Sankyo Co., LTD. in 1991, and has worked for Daiichi Sankyo Co., LTD.since 2007. After engagement in clinical development department and regulatory affairs department for over 20 years, and moved to pharmacovigilancedepartment. Currently, he is in charge of safety planning for the several therapeutic areas such as CV, oncology, CNS, vaccines and contrast agents.