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Ottawa Marriott Hotel

2017年10月17日 (火) 午前 7:00 - 2017年10月18日 (水) 午後 3:00

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA Annual Canadian Meeting

Session 6A: Perspectives on Continuous Manufacturing Approaches and Recent Developments in the Quality of Pharmaceuticals

Session Chair(s)

Loretta  Del Bosco

Loretta Del Bosco

Director, Regulatory Affairs Quality Assurance Operations

AbbVie Corporation, Canada

This session will provide the Regulator and Industry perspectives on continuous manufacturing approaches. From initial formulation and process development activities to manufacturing, the session will highlight key lessons learned and future opportunities in this exciting area of pharmaceutical products. This session will also have updates from Health Canada on several key regulatory Quality guidelines for the regulation of pharmaceuticals.

Speaker(s)

John  Groskoph, MBA

A Risk-Based Approach to Development and Manufacture of a New Chemical Entity Using Continuous Manufacturing (PCMM)

John Groskoph, MBA

Pfizer Inc, United States

Executive Director, Global CMC

Daniel  Blackwood

Speaker

Daniel Blackwood

Pfizer Inc, United States

Director, Pharm Science Technology and Innovation

Daniela I. Decina, MSc

Continuous Manufacturing of Biological Therapeutics: Current Technology Trends and Their Regulatory Impact

Daniela I. Decina, MSc

Mapi Group, Canada

Senior Director, Regulatory Affairs, CMC

Alison  Ingham, PhD

Update on Health Canada's Quality Guidance for NDSs and ANDSs and on the Use of EDQM's Certificates of Suitability (CEPs) within the Canadian Regulatory Framework

Alison Ingham, PhD

Health Canada, Canada

Team Leader, Generic Drugs Quality Division

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