Pharmacovigilance Risk Assessment Committee (PRAC) Present At SMi’s 3rd Annual Event On Pharmacovigilance, London UK
In recent weeks, The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restrictions in the use of strontium ranelate (Protelos/Osseor) to reduce the risk for adverse cardiac events in postmenopausal women and will move ahead with a more in-depth risk-benefit evaluation.
The PRAC review of Protelos/Osseor was carried out as part of a routine PSUR assessment of the medicine.
Following on from this, Dr Doris Stenver, Member of the Pharmacovigilance Risk Assessment Committee (PRAC) EMA, will be presenting at SMi’s 3rd annual Pharmacovigilance conference on “New Pharmacovigilance Legislation” taking place on 1st and 2nd July, London, UK Presentations highlights will include:
- Pharmacovigilance characteristics past and present
- First experiences in the Pharmacovigilance Risk Assessment Committee
- Status of implementation of new legislation
- Transparency Initiatives – do they make a difference?
With concerns occurring across the board in relation to PV auditing, companies face the challenge of understanding the key considerations when presenting to auditors. Pharmacovigilance 2013 will aim to unravel the challenges in compiling and presenting the new PSUR to external regulatory bodies and determine what these regulatory bodies have learnt in the wake of its recent introduction.Attendees will hear from those at the heart of legislation implementation, from the European Commission, EMA, Federal Agency for Medicinal and Health Products and industry professionals, how to steer this vital shift in pharmacovigilance regulation.
For further information on the event please click here.
Source: SMi Group