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Royal Maxim Palace Kempinski

2019年10月16日 (水) 午前 8:00 - 2019年10月17日 (木) 午後 5:00

1st Settlement, Eastern Ring Road, New Cairo, 11477, Egypt

DIA North Africa Regulatory Conference

The collaborative platform for connecting Regulatory experts in North Africa

Session 3: Biotherapeutic Products and Biosimilars

Session Chair(s)

Susanne  Ausborn, PhD

Susanne Ausborn, PhD

Global Head International Regulatory Policy

Roche, Switzerland

Myriam  Sedrati

Myriam Sedrati

Regulatory Affairs Director North and West Africa

Merck Sharp & Dohme, Morocco

• Updates from the Region: o Morocco o Algeria o Tunisia • Vaccines Registrations • Biotherapeutic products: Clinical aspects to be addressed

Speaker(s)

Hye-Na  Kang, DVM

WHO Guidelines

Hye-Na Kang, DVM

Access To Medicines and Health Products, World Health Organization, Switzerland

Scientist

Kawaldip  Sehmi

Patients’ Perspective on Biosimilars

Kawaldip Sehmi

International Alliance Of Patients' Organizations (IAPO), United Kingdom

CEO

Virginia  Acha, PhD, MSc

Interchangeability and Extrapolation

Virginia Acha, PhD, MSc

Merck Sharpe & Dohme LLC , United States

AVP, Global Regulatory Policy

Houda  Ben Khedija

• Updates from the Region: Tunisia

Houda Ben Khedija

Ministère de la santé publique, Tunisia

Directeur de l’Inspection Pharmaceutique

Peter J. Pitts

Peter J. Pitts

Center for Medicine in the Public Interest (CMPI), United States

President

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