Advanced Pharmacovigilance (London, United Kingdom - September 24-26, 2018) - Research and Markets

DUBLIN--()--The "Advanced Pharmacovigilance" conference has been added to Research and Markets' offering.

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

Key Topics To Be Covered

  • Training for Drug Safety Reporting Duties, Audits and Expectations Risk Based Inspections
  • The DDPS retirement and the New PV Master file in the EU
  • Compliance and Drug Safety
  • Product Safety Reviews Purpose and Function (incorporating the new EU Signal Analysis Requirements)
  • Developing Company Core System Information CIOMS III
  • Safety Reporting in Licensing Agreements
  • PSURs Timing, Content and the DSUR and the New ICH E2C (2nd Revision requirements)
  • Implications for Safety Reporting in Global Clinical Trials
  • Risk/Benefit Determinations
  • Risk Management Plans

Agenda:

Programme - Day one

09.00 Registration and Coffee

09.30 Start of meeting

Due Diligence

Training for Drug Safety Reporting Duties

Audits and Expectations

Compliance and Drug Safety

The PV Master File and the DDPS

17.00 Close of day one

Programme - Day Two

09.00 Start of day two

Product Safety Reviews - Purpose & Function

Interactive Exercise: Designing the Requirements for a Safety Review Group

Safety Reporting in Licensing Agreements

Developing Company Core Safety Information - CIOMS III

Interactive Exercise: Deciding whether New Safety Data presented from a Clinical Trial should be put into Core Safety Information

PSURs and the New Revisions in ICH E2C

17.00 Close of day two

Programme - Day Three

09.00 Start of day three

The EU Clinical Trials Directive

Risk/Benefit Determinations

Interactive Exercise: Reviewing the Safety of a Product

Risk Management Plans (including new EU requirements 2012)

Crisis Management within Drug Safety

Interactive Exercise: Deciding how to Handle a Major Crisis within the Company

16.30 Close of day three

For more information about this conference visit https://www.researchandmarkets.com/research/6wg67j/_advanced?w=4

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Drug Discovery

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Drug Discovery