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Session 1: Key Note Presentation
Session Chair(s)
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)
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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