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Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing

Start Date:
Monday, 2 October, 2017
End Date:
Friday, 6 October, 2017 4:00pm
Health & Nutrition

This Joint MHRA/DIA training course is designed to provide a firm grounding in key aspects of European Clinical Pre- and Post-Marketing Safety regulatory requirements. This five-day training course also includes highlights and updates on the pharmacovigilance legislation and the latest news on the international harmonisation and standardisation activities in pharmacovigilance. For the five key topics as outlined below, the learning objectives also include the ability to: • Describe the expedited and periodic ICSRs reporting requirements in clinical trials andpost-marketing including the medical evaluation• Understand the process of audits and inspections in pharmacovigilance• Understand the principles of signal management• Describe the components of the risk management Key Topics• Definitions and Methods in Pharmacovigilance• Regulatory Aspects in Pharmacovigilance and Practical Examples• Diagnosis of Adverse Drug Reactions• Signal Detection and Signal Management- Modern Technologies and Social Media• Risk Management Who Will AttendThis course will benefit professionals with minimum 1-2 year experience in Pharmacovigilance or adjacent functions, for example, PV Officers, PV Specialists, PV Experts, PV Coordinators,Heads/Directors/Managers of Regulatory Compliance, Quality or Safety departments.Level: Intermediate PriceMember Industry: EUR 3320Non-member Industry: EUR 3475Member Academia/Charitable/Government/Non-profit (Full-time): EUR 1660Non-member Academia/Charitable/Government/Non-profit (Full-time): EUR 1815 Speakers: Gaby L.

Danan (Pharmacovigilance Expert, France), Phil Tregunno (Signal Management Unit Manager, MHRA, UK) Category: Conferences | Science, Health & Medicine | Pharmaceuticals | Drug Development


The Crystal,
One Siemens Brothers Way,
Royal Victoria Docks,
London E16 1GB,
United Kingdom

Organizer Details

Conference organized by DIA EMEA

41 61 225 5151

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