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Learning Outcomes

CPD Certified
You can credit training/learning hours towards your professional accreditation by participating on this CPD certified forum.

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Day one

08:30 Welcome Coffee and Registration
08:45 Greeting from the Project Leader & GLC Icebreaker Session
08:50 Opening Remarks from the Chair

09:00 – 09:30 New regulations on the horizon
10:00 – 10:30 Audits and inspections in the EU
12:15 – 15:45 Know-hows in establishing a Risk Management Plan
16:00 – 17:00 Fundamentals of Signal Management in the EU

Day two

09:00 – 09:30 PRAC Updates
10:00 – 10:30 New requirements for Electronic Reporting
12:15 – 15:45 Medication errors in the EU
16:00 – 17:00 Mitigate the costs of PV Outsourcing

Speakers

Become a speaker
Karsten Lollike
Karsten Lollike Corporate Vice President
Novo Nordisk A/S
Denmark
Doris Irene Stenver
Doris Irene Stenver Member of the Pharmacovigilanc Risk Assessment Committee
(PRAC) at European Medicines Agency (EMA)
Denmark
Professor Saad Shakir
Professor Saad Shakir Director
Drug Safety Research Unit
United Kingdom
Giovanni Furlan
Giovanni FurlanEU QPPV
Helsinn Birex Pharmaceuticals
Ireland
More speakers

Who will you meet?

Senior Pharmacovigilance Regulators and Inspectors, Pharmacovigilance and Drug Safety Officers, Regulatory Affairs Officers, Clinical Risk-Benefit Groups, Local Medicines Authorities, CRO and Consultants providing QPPV Services, Pharma Industry Heads, Directors and Managers OF:

  • Compliance
  •  Drug Safety Officers
  • Global Drug Safety Officers
  • Heads of Safety and Pharmacovigilance
  • Inspection and Audit
  • International PV Auditors
  • Lead Safety Scientists
  • Medical Affairs
  • Patient Safety
  • Pharmacoepidemiology Pharmacovigilance
  • Consultants
  • Pharmacovigilance Managers
  • Pharmacovigilance Team Leaders
  • PSMF
  • PV Quality System
  • QPPV Personnel’s
  • Regulatory Affairs Managers
  • Safety & Risk management Safety
  • Evaluation
  • Safety Surveillance Senior Safety
  • Specialists
  • Signal Detection

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