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The Crystal

04 oct 2017 8:00 a.m. - 05 oct 2017 8:00 p.m.

1 Siemens Brothers Way, Royal Victoria Dock, London, E16 1GB, United Kingdom

11th Annual Forum for Qualified Persons in Pharmacovigilance

This is the only forum designed for QPPVs by QPPVs, now in its 11th year and ever growing. This year’s objectives build on past successes and have been shaped by valuable feedback provided by participants.

Session 1: Key Note Presentation

Session Chair(s)

Michael  Richardson, MD, FFPM, FRCP

Michael Richardson, MD, FFPM, FRCP

Senior Vice President, WorldWide Patient Safety

Bristol-Myers Squibb, United Kingdom

The environment in which the pharmaceutical industry lives has seen dramatic changes in the past decade driven by changing legislation, heightened patient expectations on efficacy and safety and funding and access of medicines controlled by payers. This changed milieu has necessitated a confluence of pharmacovigilance, development and commercialisation of medicines to engage earlier and more transparently with regulators and payers: This session will ask key regulators and Industry the following questions:

  • Have the deliverables of transparency, simplification and enhanced evaluation of benefit risk been achieved?
  • Have regulators and Industry in particular the QPPV better oversight and insight to the use of medicines
  • Have Patients and Healthcare providers received better and clearer information on the products they use?
  • In the changed global environment have Industry achieved optimal organisational and functional models to continue successful delivery of new medicines and ensure safe and appropriate use and access of these
  • Does Senior leadership in Industry support the role of the QPPV and the principle of single point oversight of the safety system?

Speaker(s)

Saad  Shakir, DrMed, MD, FFPM, FISPE, FRCP

Impact of Parts of Pharmacovigilance in the EU

Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

Drug Safety Research Unit, United Kingdom

Director

June  Raine, MD, MSc, FRCP

June Raine, MD, MSc, FRCP

Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Chief Executive

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