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  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    FUTURE ISSUES INCLUDING BROADENING THE SCOPE OF THE GLP

    PRINCIPLES

    Francisca E. Liem

    U.S. Environmental Protection Agency 1200 Pennsylvania Ave, NW 2225A

    Washington, DC 20460

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    MILESTONES OF THE GLPS

    1982 OECD Principles of GLP

    1997 OECD Principles of GLP (Revised)

    OECD

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    ELECTRONIC DATA AND RECORD KEEPING

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    OECD GUIDANCE DOCUMENT NO. 10

    The Application of the OECD Principles of GLP to Computerized Systems

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    U.S. ENVIRONMENTAL PROTECTION AGENCY

    Cross Media Electronic Reporting and Record Keeping Rule

    CROMERRR August 31, 2001 – Draft rules on Electronic Reporting and Record

    Keeping (Cross Media Electronic Reporting and Record Keeping Rule - CROMERRR)

    October 13, 2005 – Final rule on Electronic Reporting (C ross Media Electronic Rule – CROMERR)

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA)

    21 CFR Part 11

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    UNITED STATES OF AMERICA FEDERAL INFORMATION PROCESSING STANDARDS

    (FIPS)

    • FIPS 186-2 – Jan 2002 – Digital Signature Standard • FIPS 186-3 – Mar 2006 – Digital Signature Standard

    (Draft) • FIPS 186-3 – Dec 2007 – RSA Strong Primes –

    Digital Signature Standard (Draft) • FIPS 190 – Guideline for the Use of Advanced

    Authentication Technology Alternatives

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    NON-CONVENTIAL PESTICIDE PRODUCTS REGISTRATION REQUIREMENTS

    • Biological/microbiological pesticides • Biocides • Public health pesticides

    – Insecticides – Rodenticides – Avicides

    • Biotechnology – Genetically Modified Organisms (GMO) – Plant Incorporated Protectants (PIP)

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    INDUSTRIAL CHEMICALS

    � Existing chemicals � Europe – REACH � USA – Test Rule

    � New chemicals � Europe - REACH � USA – Consent Testing Agreement

    � Fuel additives � Nanotechnology

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    OTHER GLP COMPLIANCE ISSUES

    • Registration dossier – Cited old data (prior 1982)

    – Cited scientific papers/publications

    – Data developed in non-GLP countries

    – Human testing

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    ARE WE READY?

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    MUTUAL ACCEPTANCE OF DATA (MAD)

    • Global economy

    • Reliance on other countries’ developed data

    – Laboratory studies

    – Field studies

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    MUTUAL ACCEPTANCE OF DATA OECD COUNCIL ACTS ON MAD

    • 1981 Council decision on MAD in the Assessment of Chemicals

    • 1989 Council decision/recommendation on Compliance with Principles of GLP

    • 1997 Council decision on Adherence of Non-member Countries to the Council Acts to MAD

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    MAD – NON OECD MEMBERS

    • Welcome and encourage • Recognized and accepted by OECD members • Challenges:

    – Small programs – Small number of test facilities – Experience

    • Collaboration with major programs

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    OTHER CHALLENGES FOR GLP MONITORING AUTHORITIES

    • More trust in test facilities that have been inspected – Slow down, less vigilant?

    • May result in data quality and integrity problems as

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    MONITORING AUTHORITY MORE VIGILANT INSTEAD OF LESS

    • Initiate inspection program of new types of products (non-conventional pesticide/chemical products)

    • Train compliance and enforcement workers – Science of the study – Inspections of new types of product

    • Change of workforce – Backfill – Expand workforce

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    INTERNATIONAL CHALLENGES FOR OECD MEMBERS

    • Harmonization of inspections of new types of products

    • Harmonization of application of Principles • Dissemination of new procedures/policies

    to the regulated community • More resources needed

    – Financial – Human

    • More flexible?

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    INTERNATIONAL CHALLENGES FOR OECD MAD MEMBERS

    • More reliance on other countries Monitoring Authorities

    • More communication needed between and among MAD members

    • OECD countries that do not have an official GLP Monitoring program

    • Registration requirements are not yet harmonized

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    IN SPITE OF CHALLENGES TO

    MONITORING AUTHORITIES

    We have come a long way since 1981

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    TH E

    W OR

    LD A CCORDING TO GLPTH

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  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    Brazil India China

    Argentina Chinese Taipei Singapore

    Turkey Thailand Malaysia

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    IN SPITE OF CHALLENGES TO MONITORING AUTHORITIES

    • We have come a long way since 1981 – Better quality of data – Better quality of final reports – Reconstruction of data – Better data integrity

    • Harmonization of GLP Monitoring programs • Harmonization of GLP inspections and study audits

    SOP s

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    SUMMARY • Technology keeps updating itself • Non conventional products to be tested and

    registered • Old data and scientific papers • MAD, new Non Members • Other challenges for the future

    – Compliance monitoring programs – Compliance monitoring authorities – International harmonization

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008

    ARE WE READY?

  • OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma),