| EN
Loading 活動

« All 活動

  • This event has passed.

HKAPI Regulatory Training Workshop Series – Seminar 4

三月 18 @ 3:00 下午 - 5:00 下午

HKAPI Regulatory Training Workshop Series- Seminar 4

Date: 18 March 2022 (Fri)

Time: 3:00 pm – 5:00 pm

RSVP: Please contact the HKAPI Office

Fee: To be confirmed

Time Topic Speaker
3:00 pm – 3:30 pm ATP Regulatory Framework including New Product Registration & Clinical Trial Applications

 

Mr. Tony Chan

Pharmacist

Drug Office

衞生署

3:30 pm – 4:00 pm Researcher’s Perspectives of Conducting Clinical Trials on ATP Prof Barbara Chan

Professor,

Biomedical Engineering Programme

Department of Mechanical Engineering

Faculty of Engineering

University of Hong Kong

4:00 pm – 4:15 pm Q&A Kim Lee (Moderator)

Chief Scientific Officer at Novartis Pharmaceuticals (HK) Ltd / Member of HKAPI Regulatory Affairs Task Force

4:15pm – 4:45pm Real World Evidence and Regulatory Policy (US & EU): Utilization of Real World Evidence in Making Regulatory Decision

 

Ms. Susan Sandler

Pharmacist

Global Regulatory Policy & Intelligence

Johnson & Johnson UK (Ltd)

4:45pm – 5:00 pm Q&A Ms. Susanna Yim (Moderator)

Associate Director Regulatory Affairs at Janssen Pharmaceutical Companies of Johnson & Johnson / Sub-team Lead of HKAPI Regulatory Affairs


About the Speaker

Susan Sandler

Director, EMEA Policy Lead, in Global Regulatory Policy & Intelligence at Janssen R&D 

Susan is a pharmacist with a regulatory affairs background in both blue chip pharma and regulatory affairs consultancy.  She has broad-ranging expertise in EU regulatory policy/intelligence, regulatory product development/strategy, late phase/compassionate use, clinical trial operations across a range of product sectors.  In her role, she engages in regulatory policy advocacy activities including representing Janssen R&D on external trade association activities and other organisations and contributing to the pharmaceutical commenting system.  In particular, she staffs the EFPIA Integrated Evidence Generation and Use Working Group.

 

 

Details

Date:
三月 18
Time:
3:00 下午 - 5:00 下午
Event Categories:
,
Event Tags:
, ,
X
Close Bitnami banner
Bitnami