DIA
Drug Information Association Logo

DISCLOSURE OF SAFETY DATA: CAN PRAC, PATIENTS AND INDUSTRY PERSPECTIVES BE RECONCILED?

Track:
The Role of Transparency and Ethics: Legal aspects

Day & Time:
March 27, 11:00AM - 12:30PM (Central European Standard Time)

Session Number:
1306

Room Number:
F2

Type:
Session

Title:
DISCLOSURE OF SAFETY DATA: CAN PRAC, PATIENTS AND INDUSTRY PERSPECTIVES BE RECONCILED?

Chair(s):
Joyce ter Heerdt, JD
Assistant General Counsel
Johnson & Johnson, Belgium

Description:
This session will set the scene for the Theme’s topic of Transparency. Why must data be disclosed by regulators and are the current disclosure obligations suited for that objective?

Presentation(s) & Speaker(s):
PRAC's Perspective
June Munro Raine, MD, MSc
Vigilance and Risk Management of Medicines Division
MHRA, United Kingdom

Industry Challenges in Managing Safety Referral Procedures, Managing the Impact in Europe
Sarah Montagne
Head of EU Regulatory Policy
Bayer Plc, United Kingdom

Patient Perspective
Marco Greco
President
European Federation of Crohn's and Ulcerative Colitis Associations , Belgium