Research and Markets has announced the addition of the "Pharmacovigilance Europe 2017" conference to their offering.
Pharmacovigilance Europe 2017 conference will give its participants an opportunity and a platform to share experiences with the likeminded individuals in the field. The conference will also provide an insight into the complexities and challenges impacting public safety and risk management, focusing mainly on drugs, biologics and medical devices and the future of PV in the globalization era.
The conference will bring together industry experts and regulators to discuss the new updates in EU legislation, operational challenges of implication of these changes, experience of implementing global risk management plans, the best and effective way forward, impact of IT and social media on PV and harmonization of different regulatory bodies.
Key Themes:
- Explore the impact of PV legislation changes and updates on industries and the best practices
- Assuring Compliance and its monitoring
- Preparing for PV audit and inspections and the role of QPPV
- Risk management plans, strategies and new risk- benefit analysis tools to improve REMS reporting
- Implementing risk management and safety surveillance methodologies for medical devices
- New approaches for risk minimization and communication
- Determining steps and strategies for more transparency and involvement of patients
- Discussing the how IT and Social media effect Pharmacovigilance and Adverse events reporting
- Discuss and review the use of databases and emerging tools for generation and detection of safety signals
- Importance of outsourcing and its effectiveness
- Harmonization of regulatory framework- developed and emerging markets
Agenda:
Day 1
8.30 - 9.30 Registration & Refreshment
9.30 - 9.45 Chairperson's opening remarks
9.45 - 10.30 Globalization & Regulations; Opening Keynote Address - Benefit/Risk Management in Pharmacovigilance today
10:30 - 11:00 How the Increasing Access to Biosimilars affects the Pharmacovigilance of Biologicals - Member State Perspective
11:00 - 11:30 Morning Coffee/Tea & Networking
11:30 - 12:00 Maintaining the quality all the way through the process
12:00 - 12:30 First Risk Management Plan for well established products
12:30 - 13:30 Networking luncheon
13:30 - 14:30 Panel Discussion - Impact on Innovation and Patenting of biosimilars
14:30 - 15:00 Digital media: Websites & Social media Impact on pharmacovigilance
15:00 - 15:30 Nawab Qizilbash, Clinical Epidemiologist & Head, OXON Epidemiology
15:30 - 16:00 Afternoon Refreshment Break - Networking & Exhibition
16:00 - 16:30 Studies for risk management and effectiveness of risk minimisation: meeting the challenges
16:30 - 17:00 Best Practices and Uses of Safety Oversight Committees
17:00 - 17:10 Chairperson's closing remarks
17:10 - 18:30 Networking Drinks Reception
Day 2
8.30 - 9.30 Registration & Refreshment
9.30 - 9.45 Chairperson's opening remarks
9.45 - 10.30 Pharmacovigilance activities for generic drugs with focus on risk management plan and safety communication
10:30 - 11:00 PV for Biologics
11:00 - 11:30 Morning Refreshment Break - Networking & Exhibition
11:30 - 12:00 MHRA Pharmacovigilance inspection: Prepare and Manage for Success
12:00 - 12:30 PV audit and inspections: the QPPV experience
12:30 - 13:30 Networking luncheon
13:30 - 14:30 Panel Discussion - Patient Support Programme
14:30 - 15:00 Proposals for a more efficient and effective drug safety
15:00 - 15:30 Post authorization safety and efficacy studies
15:30 - 16:00 Afternoon Refreshment Break - Networking & Exhibition
16:00 - 16:30 Using pharmacovigilance databases to facilitate the detection of adverse events and the generation of safety signals
16:30 - 17:00 Outsourcing
17:30 - 17:05 Chairperson's closing remarks and end of conference
For more information about this conference visit http://www.researchandmarkets.com/research/h97s7w/pharmacovigilance
View source version on businesswire.com: http://www.businesswire.com/news/home/20170123005879/en/