LONDON, UNITED KINGDOM - Feb 18, 2015 - SMi’s 4th annual Pharmacovigilance, Drug Safety and Risk Management conference will strengthen knowledge of key Pharmacovigilance issues as well as navigate through the challenges of compiling PSUR’s and frequent safety reports. Understanding legal guidelines, EU harmonisation initiatives, benefit risk assessments and the analysis of adverse drug reactions will be a major focus, as will hearing from a selection of medical bodies and industry KOLS who will be providing PRAC and Eudravigilance updates.

Highlights this year include an address from Novo Nordisk Senior Safety Surveillance Advisor, Dr Kashif Sheikh. The presentation entitled: Pharmacovigilance management & risk minimisation procedures to ensure drug safety, will provide unique insights on drug safety and product life cycle management. Dr Sheikh will answer questions such as: Can we strengthen the link between a drug and its related adverse events from pre-clinical to post-marketing? How do we measure the effectiveness of risk minimisation activities?

Other Key Speakers Include:

• Jim Slattery, Statistician, Pharmacovigilance, European Medicines Agency (EMA)
• Dr. Tomas Moraleda , International Medical Officer, MedDRA MSSO
• Doris Irene Stenver, Chief Medical Officer, Danish Health and Medicines Authority, Member of PRAC
• Dr. Pipasha Biswas, Executive Director & QPPV, Symogen Ltd
• Dr. Michael Merz, Chair Investigative Liver Expert Team, Novartis Institutes for Biomedical Research
• Shelley Gandhi, Director of Pharmacovigilance and Drug Safety, NDA Group

To download a brochure or for the full speaker line up visit http://www.smi-online.co.uk/goto/2015pharmacovigilance40.asp

In addition to the event, there will be 2 conference workshops taking place on the 13th May 2015 entitled:

• MedDRA Coding Guidelines (Hosted by The International Medical Officer from MedDRA MSSO, Dr Thomas Moraleda)

Targeted towards those involved with coding guidelines and associated standard operating procedures. This workshop will provide an understanding of the scope, structure, and characteristics of MedDRA. The application of the terminology in coding clinical data will also be discussed.

• Risk Minimisation and Signal Management (Hosted by PharSafer Associates CEO, Graeme Ladds)

With an ever increasing focus on monitoring the risk-benefit profile of a product, this workshop will explain the role of safety review, signal detection, risk assessment and risk minimisation in the modern pharmaceutical company.

For those who are interested in attending, there is currently a £300 discount available which expires on 27th February.

For more information or to register visit http://www.smi-online.co.uk/goto/2015pharmacovigilance40.asp

Pharmacovigilance, Drug Safety and Risk Management
11th - 12th May 2015
Holiday Inn Regents Park Hotel, London, UK.
http://www.smi-online.co.uk/goto/2015pharmacovigilance40.asp

-------------------------- END --------------------------

About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk