Over 50 attendees representing leading pharmaceutical organisations and global biotechnology companies, and internationally renowned academic institutions.
Presentations, case studies, workshops and panel discussions focused on the key issues in new harmonization initiatives, benefit risk optimization and legislation.
One to one meetings, exhibition and informal networking opportunities.
4 Interactive Main Topics
- New strategies in benefit risk optimization, risk communication, labelling & packaging, and harmonization
- Addressing drug counterfeiting issues & evaluating possible measures to combat & protect consumers
- EU and US and Asian reforms in pharmacovigilance legislation
-
Preparing for product specific inspections & compliance monitoring by
authorities
Agenda
Day 1
08:30 - Coffee and registration - An opportunity to meet and to network with your conference colleagues
09:30 - Chairperson opening remarks
09:40 - Monitoring of Risk Minimisation Measures
10:20 - PV Aspects of Patient Support/Market Research Programmes and other Externally Facing Activites
11:00 - Morning Coffee/Tea & Discussion
11:30 - Use of real-world evidence (RWE) in pharmacovigilance
11:50 - Post Registration Trials-role in PV
12:30 - Networking luncheon
13:40 - Panel Discussion - Future of PV - Where are we heading?
14:30 - Effective risk management: strategies's to leverage patient safety
15:10 - Afternoon Tea/Coffee
15:30 - Challenges maintaining compliance and effective PV operations in a changing world?
16:10 - Automated PV data processing and its game changing prospect
16:50 - Chairperson's closing remarks and end of conference
17:00 - 18:00 - Networking Drinks Session
Day 2
08:30 - Coffee and registration - An opportunity to meet and to network with your conference colleagues
09:30 - Chairperson opening remarks
09:40 - Integrating Signal and Risk Management from a Small to Medium sized company's perspective
10:20 - RMP's and updates to GVP2 / dilemmas with Core and Local RMP's
10:50 - Morning Coffee/Tea & Discussion
11:10 - Keynote Panel Discussion - Enhancing communications between - Sponsor - Site - CRO & Patients
11:50 - PV in low & middle income countries & how high income countries and the industry can do more to improve patient safety in these resource scarce settings
12:30 - Networking luncheon
13:30 - Panel Discussion - Implementing risk minimization procedures - Making sure we succeed
14:10 - Challenges maintaining compliant and effective PV operations in a changing world
14:50 - Practical Advice on the of principles of GVP Rev 2
15:20 - Afternoon Tea/Coffee
15:40 - Why does pharmacovigilance sometimes fail and where/could the fault lie?
16:20 - Panel Discussion: Keeping abreast with the changing regulations of PV