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Recording of ADRs

Pharmacovigilance during clinical development SAE reporting, ASUR and PSUR IFF Seminar, 21. February 2007. Recording of ADRs. EU Directive 2001/83/EC:

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Recording of ADRs

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  1. Pharmacovigilance during clinical developmentSAE reporting, ASUR and PSUR IFF Seminar, 21. February 2007 H. Lundbeck A/S20-Sep-141

  2. Recording of ADRs EU Directive 2001/83/EC: The Marketing Autorisation Holder (MAH) shall be required to maintain detailed records of all suspected adverse reactions occuring either in the Community or in a third country. MAH shall have a global ADR system H. Lundbeck A/S20-Sep-142

  3. Agenda • Reporting of SAEs • Annual Update Reports • Periodic Safety Update Reports H. Lundbeck A/S20-Sep-143

  4. Directive 2001/20/EC and Guidance EU Clinical Trial Directive 2001/20/EC (4 April 2001): • This Directive came into force 1 May 2004 • Safety articles: • Article 2: Definitions • Article 16: Notification of Adverse Events • Article 17: Notification of Serious Adverse Reactions • Article 18: Guidance concerning reports • Detailed guidance on: • The European clinical trials database (EUDRACT database) • The European database of SUSARs • Collection, verification and presentation of adverse reactions reports arising from clinical trials. H. Lundbeck A/S20-Sep-144

  5. Adverse Events vs. Adverse Drug Reaction AEs ADRs H. Lundbeck A/S20-Sep-145

  6. Assessment Sponsor has to perform evaluation of: • Seriousness • Expectedness/listedness • Causality • Reportable H. Lundbeck A/S20-Sep-146

  7. Serious Adverse Reaction Definition A serious adverse reaction is any untoward medical occurrence or effect that at any dose: • results in death, • is life-threatening, • requires hospitalisation or prolongation of existing hospitalisation, • is a congenital anomaly or birth defect, • is medial important H. Lundbeck A/S20-Sep-147

  8. Expectedness/Listedness Company Core Safety Information (CCSI) Listedness Summary of Product Characteristics (SPC) Expectedness H. Lundbeck A/S20-Sep-148

  9. Causality An assessment of the relationship between the drug and the ADR Probably Possibly Not related H. Lundbeck A/S20-Sep-149

  10. Definition of SUSAR • Suspected Evaluated by sponsor and/or investigator as possible/probable related to IMP • Unexpected Evaluated by sponsor as unexpected according to the reference document • Serious (death, life-threatening, hospitalisation, ect.) • Adverse Reaction Any untoward and unintended response to an IMP related too any dose administered H. Lundbeck A/S20-Sep-1410

  11. Whom to report to? MAH must report all relevant safety information to: • the concerned competent authorities • the Ethics Committees concerned • all investigators concerned H. Lundbeck A/S20-Sep-1411

  12. Competent AuthoritiesWhat and when to report? Clinical trials: • Fatal and life-threatening SUSARs: • no later than 7 calendar days • Other SUSARs • no later than 15 calendar days Post-marketing: • no later than 15 calendar days The clock starts (day 0) on the date when any personnel of the MAH first receive a case report that fulfill the minimum criteria H. Lundbeck A/S20-Sep-1412

  13. Ethics Committees (ECs) Only receive individual reports of SUSARs that occurred in that Member State, provided that: • All SUSARs from Member States and third countries are reported at least quarterly as a line listing and a brief report. • Other changes increasing the risk to subjects should be provided as soon as possible within 15 days H. Lundbeck A/S20-Sep-1413

  14. Investigators Line listings of SUSARs in periods as warranted by the nature of the clinical development project and the volume of SUSARs generated. Accompanied by a concise summary of the evolving safety profile of the IMP The blind should be maintained when possible and appropriate H. Lundbeck A/S20-Sep-1414

  15. Annual Safety Report - content ADRs from clinical trials produced on one drug substance. • Report on subjects’ safety • Line listing of all SARs (unblinded) • Aggregated summary tabulation of SARs (unblinded) May trigger amendments to study protocol, changes and updates to the IB H. Lundbeck A/S20-Sep-1415

  16. Annual Safety Report - reporting To concerned competent authorities and Ethics Committees Reporting responsibility starts with the first authorisation in any Member State– the date is used for cut-off date for data to be included MAH should submit the report within 60 days of data lock point H. Lundbeck A/S20-Sep-1416

  17. Directive 2004/27/EC and Guidance Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use • Article 101 to 108 • Into force 20 November 2005 Guidance documents: • Volume 9A of The Rules Govering Medicinal Products in the European Union of January 2007 • Pharmacovigilance for Medicinal Products for Human Use • ICH E2C incl. Addendum, latest of Febuary 2003 H. Lundbeck A/S20-Sep-1417

  18. Periodic Safety Update Report (PSUR) Definition • An update of the world-wide safety experience with a medicinal product • A condition for marketing authorisation • Prepared for Regulatory Authorities Objective • Safety of the product is in accordance with previous knowledge. • To indicate whether changes should be made to the product information. H. Lundbeck A/S20-Sep-1418

  19. PSUR - Source of information Adverse drug reactions (ADRs) from: • spontaneous notifications • marketing authorisation holder sponsored clinical studies or named patient (compassionate) use • literature • reports on ADRs exchanged between contractual partners (e.g. licensors-licensees) • data in special registries • epidemiological databases H. Lundbeck A/S20-Sep-1419

  20. PSUR - Reporting PSURs should be submitted at the following times from the International Birth Date: • immediately upon request • 6-monthly for the first 2 years after authorisation • annually for the subsequent 2 years • at the first renewal • thereafter 5-yearly at renewal. MAH should submit the report within 60 days of data lock point H. Lundbeck A/S20-Sep-1420

  21. Questions Questions H. Lundbeck A/S20-Sep-1421

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