In such turbulent times, pharmacovigilance has been also affected by the unexpected changes of the World. BREXIT and Trump tornado, what else to come? In order to stay up-to-date our 5th Annual Pharmacovigilance Forum is a perfect opportunity to hear the most important updates of the industry. We bring together the top minds of the pharmaceutical industry from all over Europe to share their experiences and best practices and to network with their peers. Topics such as BREXIT vs. Pharmacovigilance, effectiveness evaluation of risk minimization measures, signal detection and Eudravigilance, GVP guidance, significance of outsourcing and many more will be discussed and consulted during our event. For those interested in Biosimilars Dr. Niraj Chhaya from Boehringer Ingelheim GmbH will present the success factor of biosimilars.
We are also happy to welcome Andrew A. Parsons on board from Reciprocal Minds Limited who will talk about human factors in Pharma R&D. This is a special feature to the event which will be a great added value to the audience.
Stay up-to-date and join our upcoming event to meet these leaders of the industry and listen their inspiring presentations in order to take home the most beneficial outcome for you and your company.
Hot Topics
Event schedule
Day one
08:30 Welcome Coffee and Registration
09:00 Pharmacovigilance in the light of BREXIT
09:40 An overview of EMA MLM’s method of literature monitoring
10:20 Switzerland- still a special country; Tips for an successful Pharmacovigilance Inspection
11:00 Tea, Coffee, Networking & Exhibits
11:30 Practical advice on the planning and conduct of
Pharmacovigilance audits in small and medium-sized
enterprises (SMEs)12:10 Current regulatory trends in PASS and PIP studies
12:40 Effectiveness Evaluation of Risk Minimization Measures: a Case Study
13:30 Luncheon & Networking
14:30 Reclassifying medicines for OTC: Assessing benefit-risk and risk minimization in a consumer setting
15:10 Human Factors – Optimising the usability of processes and technology in Pharma R&D
15:50 Tea, Coffee, Networking & Exhibits
16:20 Why does pharmacovigilance sometimes fail and where could the fault lie?
17:00 Pharmacovigilance of Antibiotics
17:40 Closing Remarks from the Chair & Networking
Day two
08:30 Meet, Greet & Networking with Welcome Coffee
09:00 Signal Detection an Eudravigilance
09:40 Signal Management – revised GVP guidance
10:20 Web-based signal detection
11:00 Tea, Coffee, Networking & Exhibits
11:20 Pharmacovigilance : The patient Perspective
12:10 Safety aspects of Patient Support Programmes and other Customer Engagement Activities
12:50 Luncheon & Networking
13:50 Pharmacovigilance for Biosimilars
14:30 Significance of outsourcing and its effectiveness
15:10 Tea, Coffee, Networking & Exhibits
15:40 Safety Alerts: An Observational Study
16:00 Holistic Approach to Combination Product Safety
17:00 Closing Remarks from the Chair & Farewell Networking
Speakers
Who will you meet?
Senior Pharmacovigilance Regulators and Inspectors, Pharmacovigilance and Drug Safety Officers, Regulatory Affairs Officers, Clinical Risk-Benefit Groups, Local Medicines Authorities, CRO and Consultants providing QPPV Services, Pharma Industry Heads, Directors and Managers OF:
- Compliance
- Drug Safety Officers
- Global Drug Safety Officers
- Heads of Safety and Pharmacovigilance
- Inspection and Audit
- International PV Auditors
- Lead Safety Scientists
- Medical Affairs
- Patient Safety
- Pharmacoepidemiology Pharmacovigilance
- Consultants
- Pharmacovigilance Managers
- Pharmacovigilance Team Leaders
- PSMF
- PV Quality System
- QPPV Personnel’s
- Regulatory Affairs Managers
- Safety & Risk management Safety
- Evaluation
- Safety Surveillance Senior Safety
- Specialists
- Signal Detection
Interested in more event information?
>>> or see event details:
- Past event videos
- Speaker panel
- Reasons to attend
- Sponsors
- Who will you meet
- Media partners
- Previous clients
- Venue and travel information
- Frequently Asked Questions