Pharmaceutical professionals, regulatory agencies and academics will share knowledge and experience at DIA Europe’s conference on the Impact of the New Pharmacovigilance Legislation on Regulatory Affairs
The event, to be held in London from 4th to 5th June, will highlight how changes in legislation will affect the way product assessment is carried out in both pre- and post-authorisation phases, introduce new obligations to Marketing Authorisation Holders, and bring in continuous benefit-risk assessment. The conference will also look at the impact of the new Pharmacovigilance Risk Assessment Committee (PRAC) on the life-cycle management of products, and the PRAC’s interactions with other committees.
Session highlights at the conference include:
- Overview of PRAC and new pharmacovigilance requirements
- The operation of the PRAC and the new Periodic Safety Update Report/Periodic Benefit-Risk Evaluation Report (PSUR/PBRER) and Risk Management Plan (RMP) requirements, including how assessments will be handled by PRAC
- Overview of the key elements for Post-authorisation Safety Studies (PASS) and Post-authorisation Efficacy Studies (PAES)
- New pharmacovigilance legislation and how it is impacting drug development
- Involvement of two sets of rapporteurs in the procedures and impact on regulatory affairs
- Referrals, opinions and conditions
- New pharmacovigilance legislation and the opportunities for regulatory affairs
- Panel discussion on impact on drug development and approval
To find out more, or to register, visit www.diahome.org/PhvImpact2013.
ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.