Detailed guidance AEs reporting in clinical trials ( CT-3 ) Stefano Bonato, M.D. Pharmacovigilance Country Head Bayer HealthCare Pharmaceuticals

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1 Detailed guidance AEs reporting in clinical trials ( CT-3 ) Stefano Bonato, M.D. Pharmacovigilance Country Head Bayer HealthCare Pharmaceuticals

2 Pharmacovigilance costs 0.12%-0.22% of hospital admissions result in death due to an ADR corresponding to 100, ,000 deaths annually in the EU 3-10 % of hospital admissions are caused by ADRs corresponding to millions annually in the EU % of hospitalised patients suffer an ADR, corresponding to million annually in the EU ADR-related costs other than those caused by hospitalization are estimated at 63.2 billion annually in the EU 79 billion represents a reasonable estimate of the total societal cost of ADRs occurring in the EU (Source: European Commission SEC (2008) 2670)

3 Aims December 2008: Proposal of three measures by the EU Commission for safe, innovative and accessible medicines for patients: 1. Modernise Pharmacovigilance to improve the safety of medicines 2. Improve patient safety by reducing the infiltration of counterfeit medicines into the supply chain 3. Improve patient access to high quality information on health and prescription-only medicines available

4 New EU PV Legislation Directive 2010/84/EU (amending Directive 2001/83/EC) implementation by 21 JUL 2012 EU Regulation 1235/2010 (amending EU Regulation 726/2004) implementation by 02 JUL 2012 Good Pharmacovigilance Practices (GVP) (will replace Volume 9a) GVP will consist of 16 modules, implementation JUL DEC 2012 A seismic shift in EU regulatory approach with major impact on industry Transition times will mean a shifting environment until 2015

5 Some changes to come (1) Definition of Adverse Event / Adverse Reaction DDPS > PV system master file (PSMF) Consumer reports > reportable Non-serious EU PM reports > reportable (90 days) Public access to EudraVigilance DB Centralisation of ICSR and PSUR submission > simplified reporting (~ 2015)

6 Some changes to come (2) PSUR: new concept, risk based frequency Measuring effectiveness of Risk minimization activities Post Authorization Efficacy Studies (PAES vs. PASS) Conditional authorisations and additional monitoring: black symbol Transparency: PSUR AR, RMP summaries > public

7 First-wave GVP modules 7 draft modules, publication of final documents June/July 2012: Module I: Module II: Module V: Module VI: Module VII: Module VIII: Module IX: PV Systems and their Quality Systems PV System Master File Risk Management Systems Data Management of ICSRs PSURs PASSs Detection and Management of Signals and information

8 Second-wave GVP modules 9 modules (drafts expected Q3), final documents expected: December 2012 Module III: Module IV: Module X: Module XI: Module XII: Module XIII: Module XIV: Module XV: Module NR: Pharmacovigilance Inspections Audits Post-Authorisation Efficacy Studies Public Participation in Pharmacovigilance Continuous PV, Ongoing Benefit-Risk Evaluation, Regulatory Action and Planning of Public Communication Incident Management Educational and Communication Tools and Materials for Pharmacovigilance and Risk Minimisation Effectiveness of Risk Minimisation Referral Procedures for Safety Reasons

9 CT-3 (Official Journal of the EU - June 11, 2011) Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use replaces: Revision 2 of the Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (April 2006) Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance Clinical Trial Module) Questions & Answers specific to adverse reaction reporting in clinical trials

10 CT-3 (Official Journal of the EU - June 11, 2011) It strengthens: Eudravigilance Clinical Trial Module (EVCTM) which will become the unique tool to collect all SUSARs reported by sponsors [Such strengthening isn t complete yet so detailed guidelines are described on transitory as well as ultimate measures]

11

12 Implications Strategic implications Resource implications Workload / staff IT solutions PASS & PAES Product information (additional monitoring / black symbol) Transparency Legal implications

13 New EU PV Legislation - summary Rationalize & strengthen the PV systems > proactive PV Simplified regulatory decision making Increased involvement of patients Increased transparency Additional activities require human and financial resources

14 Current trends > proactive PV More reporting More focus on benefit-risk More transparency

15 Thank you!

The information contained in these slides is for general purposes only and presents the state of knowledge at November 30, 2011

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