ComplianceOnline

The Changing Face of Pharmacovigilance and Drug Safety Compliance and Inspections: Implications and Best Practices for Companies Marketing Drugs in EU

Instructor: Dr. Elliot Brown
Product ID: 700081
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
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(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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The relevant EU legislation and the new guidelines on monitoring and compliance. Findings from recent EU inspections and from independent audits carried out by the presenter over the last 5 years are presented and discussed.

Description

This seminar looks at the changing face of pharmacovigilance inspection worldwide being dictated by practices originating in the European Union.

It focuses on the implications for companies currently marketing medicines in the EU, or with aspirations to do so. The webinar will summarise the relevant EU legislation and the new guidelines on monitoring and compliance. Findings from recent EU inspections and from independent audits carried out by the presenter over the last 5 years will be presented and discussed.

Areas Covered in the Seminar:

  • New EU regulations and guidelines on pharmacovigilance
  • New compliance and monitoring guidelines in Europe
  • What to expect in an EU pharmacovigilance inspection – when carried out within Europe, the US or elsewhere
  • Findings from EU inspections
  • Findings from independent audits
  • Implications for companies large and small with EU products
  • Interactions between EU and US agencies
  • What the future holds?

Who Should Attend:

  • Compliance officers of companies with drugs or biological products on the market in the EU
  • Regulatory affairs staff of companies with contractual arrangements with third parties with products on the market in the EU (service provision or licensing agreements)
  • Executives of companies planning to apply for marketing authorization in the EU
  • Managers working in pharmacovigilance, quality assurance, system and IT support, legal affairs

Instructor Profile:

Dr. Elliot Brown, trained and worked as a family physician, then spent 10 years in senior positions in various companies. He was an assessor (reviewer) for 5 years at the UK regulatory authority (MHRA) and was UK representative on the EMEA’s CPMP Pharmacovigilance Working Party, the principal drug safety assessment and rule-making body in the EU. He was EU representative on the ICH M1 (MedDRA) Expert Working Group, a member of the WHO Uppsala Monitoring Centre signal review panel and a founding member of the CIOMS working group on Standardised MedDRA Queries.

For the last 7 years, Dr.Brown has been Managing Director of Elliot Brown Consulting, an international firm of consultants specialising in pharmacovigilance / risk management / regulatory compliance. He has performed many independent pharmacovigilance audits for companies large and small in 4 continents.

Dr. Brown holds an Honorary Senior Lecturer position at the University of London’s School of Hygiene and Tropical Medicine. He is a member of the Editorial Boards of the journals Drug Safety, Current Drug Safety and the International Journal of Pharmaceutical Medicine and has published extensively on pharmacovigilance and associated topics as well as chairing and speaking at numerous international conferences.

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