European enforcement of pharmacovigilance and inspection trends
Download
1 / 10

European Enforcement of Pharmacovigilance and Inspection Trends - PowerPoint PPT Presentation


  • 115 Views
  • Uploaded on

European Enforcement of Pharmacovigilance and Inspection Trends. Is compliance possible within the EU? June 7, 2007 Dr. M.C. Koster CEO Vigilex Group. Europe. 27 EU member states (per 1 January 2007) 3 European EFTA countries have chosen to follow the EU legislation & guidance for PV

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about ' European Enforcement of Pharmacovigilance and Inspection Trends' - xanti


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
European enforcement of pharmacovigilance and inspection trends

European Enforcement of Pharmacovigilance and Inspection Trends

Is compliance possible within the EU?

June 7, 2007

Dr. M.C. Koster

CEO Vigilex Group


Europe
Europe

  • 27 EU member states (per 1 January 2007)

  • 3 European EFTA countries have chosen to follow the EU legislation & guidance for PV

    (Norway, Iceland and Liechtenstein)

  • Together, these 30 countries are referred to

    as the EEA (European Economic Area)


Requirements for a mah
Requirements for a MAH

  • QPPV, residing within the EEA and permanently and continuously at his disposal

  • Single QPPV for all products and responsible for:

    • overview of safety profile all products

    • establishment, maintenance/management of the PV system

    • oversight in terms of structure and performance of e.g. staffing, procedures, database(s), training, QC processes and QA activities

    • timeliness and correctness of expedited and periodic reports submitted

    • ongoing risk-benefit evaluation of all products

    • ensure any request from a competent authority is answered fully and promptly

    • must provide any information relevant to the evaluation of benefit and risk

    • Etc., Etc.


Requirements for a ca
Requirements for a CA

  • EC is the CA for pharmaceutical products authorised centrally and has the responsibility for the overall community system of PV; assisted by the CHMP and EMEA (European Medicines Agency)

  • Individual MSs have the responsibility for all other products when there is a marketing authorisation in their country (national procedures, including the mutual recognition and decentralised procedure)

    • continually monitors the safety profile of the products available on its territory and takes appropriate action where necessary and monitors the compliance of MAHs;

    • should ensure that MAHs implement, when appropriate, Risk Management Plans to effectively monitor and manage risks associated with the safety of their products;

    • should ensure that PV data are shared between Member States and the Agency via EudraVigilance;

    • shall ensure, by repeated inspections, compliance with required activities


“If the law supposes that,” said Mr. Bumble,… “the law is aass—an idiot. If that’s the eye of the law, the law is a bachelor; and the worst I wish the law is that his eye may be opened by experience.”

CHARLES DICKENS, Oliver Twist, chapter 51, p. 489


Examples of obstacles
Examples of obstacles law is a

  • 15 c-day deadline for expedited reports, but no sign off by CAs during the weekend or bank holidays

  • Electronic reporting mandatory since November 2005; many CAs not ready yet

  • Good PV staff is rare and so is a QPPV

  • Volume 9A, containing a substantial number of changes, is in effect immediately

  • Volume 9A will be regularly updated (225 pages), but changes are not marked

  • Still countries requiring reports in national language


Examples of duplication
Examples of duplication law is a

  • Literature searches

    • MAHs are expected to maintain awareness of individual case reports in publications through accessing weekly a widely used systematic review and reference database

    • For a company wit 100 products this involves at average 110-120 hours a week

  • PSUR review for nationally authorised products, in principle, by 30 EEA countries

  • Expedited reports could be sent all to the EudraVigilance database in stead of in a complex structure to individual MSs


Inspection trends
Inspection trends law is a

A. Routine

  • National inspection programs

  • For centrally authorised products the CHMP will determine a program

    B. Targeted

  • Triggered but without a specific concern

  • Triggered but with a specific product or actual non-compliance

    Outcome of inspections are not predictable as findings vary per country and per inspector


Recipe for benefit to public health
Recipe for benefit to public health law is a

  • Reporting to EudraVigilance only

  • Use resources better:

    • simplified PSURs for older products

    • simplify reporting for older products

    • No global & local literature searches by all companies

  • Exempt PV from the strict data privacy Directive

  • Abandon the macho behavior of individual countries

  • Harmonise, Harmonise, Harmonise, Harmonise


Questions

QUESTIONS? law is a

[email protected]

www.vigilex.com


ad