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23-Jan-2019

3-Day Course: Advanced Pharmacovigilance (London, United Kingdom - March 25-27, 2019) - ResearchAndMarkets.com

The "Advanced Pharmacovigilance" conference has been added to ResearchAndMarkets.com's offering.

This three-day course is designed for those with at least two years' knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company.

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

The course covers very diverse activities within the safety department and would be advantageous to those who have either multifunction responsibilities or medical directors who manage teams in the various disciplines.

Benefits of attending:

  • Expand your global safety knowledge
  • Enhance your team's capabilities and compliance in both the regulations and your company's expectations
  • Help ensure you build and maintain a quality pharmacovigilance department ready for any pharmacovigilance inspection
  • Participate in group workshop sessions and discuss how to apply the legislation to ensure compliance, especially to satisfy regulatory inspections
  • Discuss the implications of Brexit

Agenda

Programme Day One

  • Due Diligence
  • Training for drug safety reporting duties
  • Audits and expectations
  • Compliance and drug safety
  • The PV System Master File (PSMF)
  • Interactive exercise - The requirements for a safety department

Programme Day Two

  • Product safety reviews - purpose and function
  • Interactive exercise - Designing the requirements for a safety review group
  • Safety reporting in licensing agreements
  • Developing Company Core Safety Information (CCSI) - CIOMS III
  • Interactive exercise - Should new safety data from a clinical trial be put into core safety information?
  • PSURs and the revisions in ICH E2C

Programme Day Three

  • The EU Clinical Trials Directive
  • Risk/benefit determinations
  • Interactive exercise - Reviewing the safety and risk/benefit of a product
  • Risk Management Plans (RMPs)
  • Crisis management within drug safety
  • Interactive exercise - Deciding how to handle a major crisis within the company

Delegates will be split into groups and present what they need to have in place in order to effectively manage the crisis and look to its resolution.

For more information about this conference visit https://www.researchandmarkets.com/research/35rgbn/3day_course?w=4

View source version on businesswire.com: https://www.businesswire.com/news/home/20190123005321/en/

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Last Updated: 23-Jan-2019