Startdate:
21 September 2012 Purpose:
One day
Hot Topic Seminar on:
Latest News within the Pharmacoviglance Legislation
Learn from key European agencies and MAH experts:
• How can you become compliant with the new EU Pharmacovigilance legislation?
• Do you have to change company definitions of relevance to safety?
September 21, 2012, 08.30 – 17.00
At Lersoe Parkallé 101, 2100 Copenhagen, Denmark
Overview:
This hot topic day will take stock on the first experiences with the new pharmacovigilance legislation and will present views and perspectives from regulators and industries. The Phamacovigilance legislation came into force by 1.1 2011 and applies from July 2012. The new legislation is considered to be the largest change in human regulatory medicine since 1995. The implementation of this legislation is therefore a huge challenge for all stakeholders - the EMA, the national agencies and the pharmaceutical industry. While the preparation of the new legislation lasted several years, the implementation phase is rapid and intensive. Within a short timeframe the pharmaceutical industry has to revise key processes in accordance with the wide range of legal provisions, implementing measures, transitional arrangements and guidelines. Ongoing dialogues between industries and legislators are therefore crucial to ensure a smooth implementation of this important legislation. Download program
Seminar Chairs:
• Doris Irene Stenver, Chief Medical Officer, Danish Medicines Agency, Denmark
• Merete Schmiegelow, Director, Regulatory Policies and Intelligence, Novo Nordisk A/S, Denmark
• Gro Laier, Deputy QP PV, Novo Nordisk A/S, Denmark
Speakers:
• Doris Irene Stenver, Chief Medical Officer, Danish Medicines Agency, Denmark
• Hillary Vass, Global Clinical Dictionary Manager, Clinical Information Standards Governance Organisation, AstraZeneca UK Limited, United Kingdom
• Sabine Straus, Head of Pharmacovigilance, Medicines Evaluation Board, The Netherlands
• Christian K Schneider, Committee for Advanced Therapies (CAT), EMA, Biosimilar Medicinal Products Working Party (BMWP), EMA, European Medicines Agency (EMA), London UK & Danish Medicines Agency, Licensing Division, Denmark
• Franck Diafouka, Business Continuity Coordinator, European Medicines Agency, United Kingdom
Content:
Programme:
08.30 – 08.45 Welcome and intro to today
• Organization and Governance of Implementation
• Commission/EMA/HMA
• List of Documents
• GVP Modules
• Implementation Measures
• PAES Delegated Act
• Product Labeling Guideline
Medicademy and Seminar Chairs
08.45 – 10.00 Transparency
• Empowerment of the Patient
• Freedom of Information
• Privacy Legislation
• Proprietary Data
• Personal Data
• EMA Web Portal
• Public Hearings
Lecturer from EMA confirmed, but not named
10.00 -10.15 Break – Coffee/Tea
10.15 - 11.30 Roles and Responsibilities including Rational Use of Resources
• Future Drug Dictionaries
• EVMPD
• ISO
• PRAC/CHMP/CMD(h)
• Monitoring of Literature
• Monitoring of Signal Detection
• Clinical Trial Cases where the MAH is not the Sponsor
• PSUR Work Share
• System Master Files – Variations
• Coordination of Safety Announcements
Hillary Vass, Global Clinical Dictionary Manager, Clinical Information Standards Governance Organisation, AstraZeneca UK Limited, United Kingdom
11.30 - 12.30 Lunch
12.30 – 14.00 Risk Based Approach
• Defifinition of ADR – e.g. Off Label Use, Medication Error, Misuse Abuse – SmPC and PL
• PSUR (PBRER) Schedules
• Risk Management Plans
• Including Publication of Summary
• List of Additional Monitoring
• Standard Text in SmPC and Patient Leaflet
Sabine Straus, Head of Pharmacovigilance, Medicines Evaluation Board, The Netherlands
14.00 - 14.15 Break – Coffee/Tea
14.15 - 15.45 Risk Benefit
• Setting the Scene
• Risk Benefit Models
• Health Technology Assessment (HTA)
• New PSUR Concept
• PASS
• PAES
Christian K Schneider, Committee for Advanced Therapies (CAT), EMA, Biosimilar Medicinal Products Working Party (BMWP), EMA, European Medicines Agency (EMA), London UK
Danish Medicines Agency, Licensing Division, Denmark
15.45 - 16.00 Break – Coffee/Tea
16.00 – 17.00 Panel Discussion
Future Perspectives – Trends and Challenges
• Social Media and organized collections Schemes
• Third World
• Other Items
Seminar Chairs, Speakers, Participants Target:
Target Audience:
The seminar is open for anyone interested in this subject, but the target audience is professionals in:
• Health care professionals
• HQ and Affiliate Safety issues
• HQ and Affiliate Pharmacovigilance
• HQ and Affiliate Regulatory Affairs
• HQ and Affiliate involved in benefit/risk bal¬ance
• HQ and Affiliate involved in observational studies and social medias |