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PANDRH

PANDRH. WG/Vaccines and WG/GLP 1-3 June, 2005. Rosario D’Alessio, THS/EV. PAHO/WHO INVOLVEMENT IN PANDRH.

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PANDRH

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  1. PANDRH WG/Vaccines and WG/GLP 1-3 June, 2005 Rosario D’Alessio, THS/EV

  2. PAHO/WHO INVOLVEMENT IN PANDRH 1. WHO MANDATE: to act as directing and coordinating authority on international health work; and to develop, establish and promote international standards with respect to biological, pharmaceutical and similar products; 2. PAN AMERICAN SANITARY CONFERENCE supports the development of essential drug policies that include drug legislation and registration; drug manufacturing and marketing; and drug use and drug financing; that promotes the establishment of pharmaceutical services and drug information for health workers and public education promoting the rational use of medicines

  3. NAFTA MERCOSUR SICA ANDEAN COMMUNITY CARICOM Groups of Economic Integrationin the Region of the Americas BILATERAL&MULTILATERAL: REGIONAL INTERREGIONAL ALADI HISPANOAMERICA ICDRA ICH

  4. Pan American Network for Drug regulatory Harmonization Pan American Conference Regulators Andean Area CARICOM MERCOSUR SICA NAFTA INDUSTRY Secretariat Steering Committee Consumers Academia Professional Ass WG WG WG WG WG WG

  5. STEERING COMMITTEE2005 - 2007 NRA Members Alternate NA: Mexico USA CA*: Costa Rica Panama CR*: Trinidad &Tobago Barbados ME*: Argentina Chile AA: Colombia Bolivia Pharmaceutical Industry One rep from FIFARMA ------------- One rep from ALIFAR ------------- * NEW

  6. PANDRH CONFERENCES • I Conference: November 1997 • Establishment of an Hemisferic Forum • II Conference: November 1999 • Establishment of PANDRH • III Conference: April 2001 • Support to harmonization processes in the Americas and first steps by WGs • IV Conference: March 2005 • Review of 10 technical documents

  7. HARMONIZATION Search for common ground within the framework of recognized standards, taking into account the different political, health, and legislative realities in the Americas Region

  8. PANDRH RULES AND REGULATIONS • Mission • Objectives • Goals • Operation www.paho.org

  9. MISSION CONFERENCE STEERING COMMITTEE The Conference should promote drug regulatory harmonization for all aspects of quality, safety and efficacy of pharmaceutical products as a contribution to the quality of life and health care of the citizens of the Member Countries of the Americas. The Steering Committee should enable progress between Conferences by coordinating, promoting, facilitating and monitoring harmonization processes in the Americas.

  10. GOALS Conference Steering Committee • To examine regulatory systems • To develop and adopt proposals for technical regulatory harmonization • To review existing regulatory requirements and guidelines for specific issues • To identify and discuss medicinal regulation implementation issues • Identify experts to ensure effectiveness and relevance of the conference • To develop/maintain an information system to disseminate advancements on harmonization • To identify mechanisms for fostering capacity building and technical & scientific cooperation • To provide information on regulatory systems

  11. OBJECTIVES Conference Steering Committee • Dialogue among participants at the conferences • Adopt recommendations • Encourage convergence of drug regulatory systems • Encourage and facilitate technical cooperation • Promote harmonization • Ensure effectiveness and relevance of the conference • Monitor implementation of conference • recommendations • Ensure continuity • Facilitate consensus - building and resolution of issues

  12. OPERATION CONFERENCE STEERING COMMITTEE 1. To organize meetings, workshops, to carry out recommendations of the Conference. 2.To establish study groups on regulatory topics identified by the Conference as more relevant. 3. To determine preparatory activities necessary for subsequent Conferences. 4.To determine the best methods to resolve issues and reach consensus. 5. To convene meetings at which a quorum of two thirds of the membership are present. 1.To promote participation by all interested parties in the Americas and those invited by the S C. 2.To be held every two years at a date and place determined by the Steering Committee. 3.To adopt all Conference recommendations and conclusions by consensus in plenary sessions. If consensus can not be reached, the different points of view will be recorded.

  13. FINANCING SOURCES • Pharmaceutical Industry Associations • Professional Associations • Governments • Conference Registration Fees • Non Governmental Organizations • Pan American Health Organization • others

  14. SECRETARIAT • 1. PAHO is the Secretariat of the Network, the Conference and the Steering Committee • 2. The Secretariat shall: • Provide administrative and technical support • Coordinate actions deriving from recommendations • Act as a clearinghouse for information • Arrange for expert advice and consultants • Act as liaison, with similar programs such as ICDRA, ICH and other national or regional trade agencies • Maintain permanent communication will the SC • Seek financial support

  15. WORKING GROUPS I • WGs are established by the SC based on Conference recommendations • WG plans of work shall be approved by the SC • WGs are coordinated by DRA (except from the GW on Pharmacopoeias) • Members are selected by the SC • Members are experts in the field (theoretical/practical) • Members represent government or institutions (The MOH shall confirm gov. representatives)

  16. WORKING GROUPS II • 7. Members are not remunerated • 8. Each WG has even number up to 9 • 9. Outside experts can participate as observers • 10. The meetings are jointly organized with other activities • 11. The Secretariat keeps a CV of WG members • 12. Members who cannot attend two consecutive meetings are no longer members • 13. The Secretariat keeps a CV of WG members

  17. WORKING GROUPS III • Members who cannot attend two consecutive meetings are no longer members 15. A substitute member in two consecutive meetings, become the member of the group 16. No one can be member of more than two WG 17. Continuity of WG members are encourage to assure effectiveness 18. WG representation will be balanced within and among countries 19. All WG meeting shall be convened by the Secretariat 20. Proposals for NEW WG should be approved by the Conference

  18. WORKING GROUPS OBJECTIVES • To assess comparative studies and identify gaps • To develop harmonized proposals to be approved by the Conference • To identify strategies to implement approved proposals • To follow up at national and/or sub-regional level • To plan cooperation between countries • To develop a working plan between Conferences • To disseminate knowledge as the advantages of regulatory harmonization

  19. PANDRH WORKING GROUPS • GMP • BE • GCP • Counterfeit • Classification • Registration • Pharmacopoeia 8. Medicinal Plant 9. Pharmacovig 10. Vaccine 11. GLP 12. Drug promotion

  20. PROCESS for DEVELOPMENT of PROPOSALS (1) (2) (3)

  21. Guidelines GMP Inspection (Final) Good Clinical Practice (Final) BE criteria (Draft) Criteria Classification (OTC) (Final) Drug Counterfeiting (Final) Implementation of PANDRH educational seminars (Final) Registration requirement (Draft) PANDRH Approved proposals

  22. Structure within NRA Executive Unit Drug Counterfeiting (Final) Processes/Strategies Pharmacopoeia monographs (Final) Road map for Combating Drug Counterfeiting (Final) Implementation strategy of PADRH Guidelines (Final) PANDRH Approved proposals

  23. PANDRH Proposals(Under development) PANDRH operation • External Quality Control Program NRA • BE criteria for BE Studies • BE list of priority drugs • Drug comparator • Drug Registration requirements • Indicators: (BE, GCP, Registration, NRA assessment GMP implementation) • List of API subject to OTC

  24. Educational Programs(developed) • GMP (Basic & Validation (WHO) • GMP (FDA) • BE (Basic & In vitro method (FDA) • HPLC Practical Application (USP)

  25. Educational Programs(under developing) • GMP Guideline Implementation • Combat drug counterfeiting • GCP for NRA • GLP • Drug Registration/Evaluation of dossiers • BE Module 2 & 3 (in vivo & data analysis)

  26. SPECIAL STUDIES(Pending) • Impact of the pharmacists in community pharmacies • Diagnostic study on Good Distribution and Good Dispensing Practices • Feasibility study for a regional / subregional entity

  27. ADVANTAGES OF PANDRH • 1. It establishes a Pan American Forum to discuss common problems • To strengthen NRA at individual level • To promote constructive participation of all sectors • To facilitate the establishment of a NDR network • 2. Strengthens health issues prioritization in the process of economic integration • To establish priorities in drug regulatory harmonization processes • To facilitate continuity of technical agreements • To encourage convergence of drug regulatory systems in the Region • 3. Improves access to Q, S & E drugs • To reduce unnecessary and duplicated requirements for drug registration which help the speed drug registration and marketing • To harmonize acceptance of international standards of Q, S & E , which improve the quality of pharmaceutical markets

  28. ADVANTAGES OF PANDRH II • 4. DRA lead and participate in the process • WGs are composed by technical staff of DRA, academia and representative from the industry. PAHO & WHO staff, and other experts participate as resource persons • 5. It promotes technical cooperation • Among countries: more developed DRA share knowledge and experiences with less advanced DRA • Among interested parties: regulators, academia, industry and between the public and the private sector • 6. Is a permanent opportunity for professional development • Training is a major component of the initiative • Improve the knowledge of international guidelines: WHO, ICH, Other region (EMEA), as well as national regulatory issues in the region • Pre or post PANDRH WGs meetings may include scientific national or international events to facilitate members participation

  29. Muchas graciasMuito obrigadaThank YouMerci

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