1 / 39

Bienvenidos

Bienvenidos. Mexico Trip Report (Summary). Bilateral FEUM-USP Meeting May 14, 2007 10:00 am – 12:00 noon FEUM facilities Mexico City, Mexico. Attendees. FEUM Carmen Becerril, FEUM Executive Director César Diaz Díaz, Manager, Relations Juan C. Gallegos, Scientific Liaison

terry
Download Presentation

Bienvenidos

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. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Bienvenidos

  2. Mexico Trip Report(Summary)

  3. Bilateral FEUM-USP MeetingMay 14, 200710:00 am – 12:00 noonFEUM facilities Mexico City, Mexico

  4. Attendees FEUM Carmen Becerril, FEUM Executive Director César Diaz Díaz, Manager, Relations Juan C. Gallegos, Scientific Liaison Ubaldo Juárez Sevilla, Executive Associate Director Rafael Hernández Medina, Manager, Publications Arturo Mendiola Condado, Scientific Liaison Luis A. Santiago Montesinos, Scientific Liaison • USP René Bravo Roger L. Williams Angela G. Long Damian A. Cairatti Gabriel I. Giancaspro Antonio Hernandez-Cardoso Horacio Pappa Victor S. Pribluda

  5. Agenda FEUM Update General Discussion Possible Memorandum of Understanding (MOU) Topics • Standards for Articles Legally Marketed Outside the U.S. (SALMOUS) Monographs • Staff and Expert Exchange • Collaborative Studies for Reference Standards • Distribution of Reference Standards in Mexico • Scientific and technical meetings, courses, conferences, and other outreach First FEUM-USP Scientific Meeting, May 15-16, 2007

  6. Action Items • FEUM will provide USP a list of monographs that it has that also appear on the SALMOUS list • USP will draft a new Memorandum of Understanding and provide it to FEUM for review • FEUM must obtain COFEPRIS approval of the MOU P:\Executive\International Affairs\Countries\Mexico\FEUM\Meetings\Meeting 09 May 2007\2007-05-14 Meeting with FEUM.doc

  7. FEUM books available in USP Library • Allopathic Pharmacopeia (FEUM) • Homeopathic Pharmacopeia • Herbal Pharmacopeia • Medical Devices Supplement • Pharmacies and Drug Store Supplement

  8. Pharmacopeial Working Group MeetingMay 14, 20072:30 pm – 3:15 pm Gran Meliá México Reforma Mexico City, Mexico

  9. Attendees • PWG Representatives • Luiz Armando Erthal, Brazilian Pharmacopoeia/ANVISA • Carmen Becerril, Méxican Pharmacopeia/COFEPRIS/FEUM • Roger L. Williams, U.S. Pharmacopeia • FEUM Staff • César Diaz • Rafael Hernández Medina • Luis Antonio Santiago Montesinos • Margarita Estrada Severiano • María del Carmen Alonso • Ana Silvia Aguillón • USP Staff, Board of Trustees Member • René Bravo • Angela G. Long • Damian A. Cairatti • Gabriel I. Giancaspro • Antonio Hernandez-Cardoso • Horacio Pappa • Victor S. Pribluda

  10. Agenda It is considered an informal meeting of the PWG due to the fact that no representative from Argentina was able to attend. Attendees more generally considered the challenge of Pharmacopeial harmonization in the Americas

  11. General Considerations • The activity has always been regarded as somewhat peripheral to the work of PANDRH because the pharmacopeias are not considered ‘ministerial’ in terms of regulatory activities; • PANDRH’s work at PAHO is in abeyance because of the departure of Rosario D’Alesio and other staff transitions • PWG secretariat now is Horacio Pappa/USP—prior to that it was Enrique Fefer at USP • All pharmacopeias in the Americas are extremely busy with their own issues, transitions, and resource constraints • Harmonization of one monograph (Amiodarone) as a model effort did not progress • Some information exchange and progress has occurred, particularly for PDG work with General Chapters • In the above contexts, a new approach to PWG activities merits consideration P:\Executive\International Affairs\PAHO\PANDRH\007 Pharmacopeias HP\Meetings\Meeting Informal May 2007\2007-05-14 PWG Informal Meeting Notes.doc

  12. USP Regional Stakeholders Forum MeetingMay 14, 20073:30 pm – 6:00 pm Gran Meliá México Reforma Mexico City, Mexico

  13. Goals and Anticipated Outcomes • Enhance USP’s reach to and communications with the Mexican, Central American, the Caribbean and Andean Countries pharmaceutical community • Exchange scientific information with the Mexican, Central American, the Caribbean and Andean Countries stakeholders • Introduce ways in which Mexican, Central American, the Caribbean and Andean Countries stakeholders can participate in USP’s standards-setting process

  14. Final Organizations Attendees List • Mexico National Chamber of Pharmaceutical Industry (CANIFARMA) • Mexico Association of Manufacturers of Over- The-Counter Medicines (AFAMELA) • Mexico Mexican Association of Pharmaceutical Research Industries (AMIIF) • Mexico Mexican Pharmaceutical Association (AFM) • Mexico Federal Commission against Sanitary Risks (COFEPRIS) • Mexico Mexican Pharmacopeia (FEUM) • Panama Minister of Health • Brasil ANVISA • El Salvador MSPAS-URMIM • Costa Rica Minister of Health • Colombia INVIMA

  15. Speakers CANIFARMA Moderator CANIFARMA President ANVISA/BRAZIL Representative FEUM Executive Director EL SALVADOR Representative COLOMBIA Representative

  16. Speakers PANAMA Representative COSTA RICA Representative AFM Representative CANIFARMA Representative

  17. Hot Topics Monographs • New/up-to-date • Existing monographs/up-to-date • Herbals/[Dietary Supplements—US] • Homeopathic Medicines (FEUM/not USP) • Colorants General Tests/Procedures • Description (Color) • Other organoleptic tests • Uniformity of Dosage Units <905> (mass/content) • <467> Residual Solvents • Microbial Limits • Particle sizing (calibration) … (continued) P:\Executive\International Affairs\Countries\Mexico\FEUM\Meetings\Meeting 09 May 2007\2007-05-14 Meeting with FEUM.doc

  18. Hot Topics Dosage Forms • BA, BE, Dissolution • Controlled Release Collaboration between Pharmacopoeias Biotechnology Drugs Counterfeits and Substandards Reference Standards • Controlled substances • Prices P:\Executive\International Affairs\Countries\Mexico\FEUM\Meetings\Meeting 09 May 2007\2007-05-14 Meeting with FEUM.doc

  19. Welcome Reception

  20. First FEUM-USP Scientific Meeting for Mexico, Central America, the Caribbeanand Andean Countries May 15 - 16, 2007 Gran Meliá México Reforma Mexico City, Mexico

  21. Meeting objectives • Disseminate scientific information and USP's current thinking on specific topics, and additional areas of quality assurance of medicines in which USP is involved, especially in Latin America. • Facilitate regional access to this information by inviting the participation of industry, regulatory agencies and academia in neighboring countries in Latin America. • Build collaborative relationships. • Provide a USP Pharmaceutical Education course on analytical methods validation.

  22. Welcoming Remarks CARMEN BECERRIL FEUM ROGER WILLIAMS RENE BRAVO JUAN A. GARCIA VILLA FEDERAL COMMISSIONER (COFEPRIS)

  23. PRESENTATIONS – DAY ONE PEDRO CASTAÑEDA (FEUM) Water for Pharmaceutical Purposes ROGER WILLIAMS (USP) Good Product Performance Practices ALBA NELIDA (FEUM) Microbiology Tests VINOD SHAH (USP) Good Product Performance Practices HORACIO PAPPA (USP) Validation and Verification of Compendial Procedures

  24. PRESENTATIONS – DAY TWO GABRIEL GIANCASPRO (USP) Botanical Products. Herbs Usage in Dietary Supplements GABRIEL MARCELIN (FEUM) New Technologies in QC of Medicines DAMIAN CAIRATTI (USP) International Standards VICTOR PRIBLUDA (USP) Latin American Programs JUAN ANGELES URIBE (FEUM) Exchangeable Generics and Tests for

  25. CLOSING SUMMARY DISCUSSION CARMEN BECERRIL (FEUM) ROGER WILLIAMS (USP)

  26. FINAL NUMBERS • 190 attendees • 110 paid attendees (80 were the FEUM expectation) • 70 complimentary attendees • Although there was indirect competition with other relevant pharmaceutical event COFEPRIS/AFM on May 17-18, 2007 • Survey Results to come … (by next week)

  27. Regulatory Meeting After the adjournment of the FEUM-USP Scientific Meeting, the invited regulatory authority representatives met informally to discuss hot topics with USP and FEUM staff. All regulatory attendees were extremely gracious in expressing appreciation for the FEUM-USP meeting and the opportunity to engage in positive dialogue on the topic of quality

  28. Regulatory Meeting Attendees—Regulatory Authorities Country Organization • Román A. Aniño Panamá Ministerio de Salud • Luiz Armando Erthal Brasil ANVISA • Manuel Mercado Chica Colombia INVIMA • María Felicia Mora Huag Costa Rica Ministerio de Salud • Mireya Orellana Hernández El Salvador MSPAS-URMIM • Cecilia Garnica López Bolivia Ministerio de Salud y Deportes • Víctor Dongo Zegarra Perú MINSA • Lucrecia Arriola Guatemala Ministerio de Salud • Lucette Cargill Jamaica Caribbean Regional Drug Testing Lab • Carmen Becerril Mexico FEUM

  29. Conclusions Dr. Williams indicated that while he has traveled extensively in Latin America and has worked in ICH, WHO, and PAHO. This effort has resulted in many good normative documents, but the kind of dialogue heard today emphasizes the importance of hands-on action and understanding of day to day problems. This action is needed in the face of many regulatory challenges. Such challenges include political interference, constrained resources, lack of training, insufficient laws and regulations, compendial differences, and aggressive, poorly informed, or even dishonest industries. Simple solutions with maximum impact are needed. Further dialogue is needed to determine how to support regulatory action in the region (Central America, SICA, Andean Countries. The discussion today focused on quality, which is sometimes given less attention given the focus on efficacy and safety. Ms. Becerril also noted the importance of pharmacovigilance, which is a functionality where FEUM is gaining expertise, with up to 12000 reports/year. She offered assistance to regulators who wished to know more about FEUM’s pharmacovigilance approaches P:\Executive\International Affairs\Countries\Mexico\FEUM\Meetings\Meeting 08 May 2007 Science Meeting\2007-05-16 Regulatory Authority Notes.doc

  30. Pharmacopeial Education CourseMay 17, 20078:00 am – 6:00 pm Gran Meliá México Reforma Mexico City, Mexico

  31. Some aspects of the PE Course

  32. Executive Outreach Visits May 17, 20078:00 am – 10:00 pmLaboratorios Kendrick (Large National Generic Company) Mexico City, Mexico

  33. Attendees Kendrick Attendees • Juan Carlos Valdez, CEO • Enrique Elmo Acosta Castillejos, Director of Research and Development and Marketing • Mercedes Reyes Guzman, Manager, Regulatory Affairs • Maria Catalina Diaz Gutierrez, Manager Quality Control USP Attendees • Rene Bravo (BOT) • Roger Williams • Angela Long • Antonio Hernandez-Cardoso • Victor Pribluda • Matt Vankoski Mexican USP Distributors • Gamaliel Gonzalez • Ernesto Gonzalez

  34. Summary • Overview of the company (Juan Carlos) • Overview of Mexican Market • Ways for USP to Assist: Registration Manufacturing Tenders Consumer Information ACTIONS • Further dialogue with Mercedes and Catalina • Provide Verification information to Catalina P:\Executive\International Affairs\Countries\Mexico\Companies\Kendrick\2007-05-17 USP-Kendrick.doc

  35. Executive Outreach Visits May 17, 200710:30 am – 12:30 pmTEVA (formerly Lemery)(Large Multinational Company) Mexico City, Mexico

  36. Attendees TEVA Attendees • Alfredo Garzon, Research and Development Director • Marcos Solis, R&D Project Manager • Araceli Garcia, Analytical Development Manager • Salvador Salado, Regulatory Affairs Manager • Ramon Rodriguez, Desarrollo Farmaceutico (translation needed) USP Attendees • Rene Bravo (BOT) • Roger Williams • Angela Long • Antonio Hernandez-Cardoso • Victor Pribluda • Matt Vankoski Mexican USP Distributors • Gamaliel Gonzales • Ernesto Gonzales

  37. Summary • Overview of Company (Alfredo)—PPT available • General Comments from Salvador Salado • Araceli manages calibrators—will send list (buy from NIST) • General Discussion ACTIONS • Further dialogue with Salvador and Araceli P:\Executive\International Affairs\Countries\Mexico\Companies\Teva Mexico\2007-05-17 USP-TEVA.doc

  38. GENERAL WEEK SUMMARY • FEUM has made great strides since USP began working with the organization in 1992. • It now has its own facility with laboratory and a staff of approximately twenty. • It publishes several compendia, including one like USP-NF, one like P2, one for homeopathic medicines, one for devices, and one for herbal medicines (similar to the DS line extension). • Reference standards efforts are beginning with 15 available now (costs ~ $80-180) with plans to add 15/year for next several years. • The private body making RS (Cosufar) has stopped its efforts. • There are problems for both FEUM and USP for controlled substances monographs and reference standards and this might form a specific ‘win-win’ activity. • USP’s activities in Mexico are less evolved than activities in either India or China. USP has had ambitious Phase 1 efforts over several years, although these have dwindled to some extent in recent years for various reasons, e.g., USP’s focus in larger countries. • There are no Phase 2 plans now, although USP has strong distributor capability (Proquifa/Gamaliel with sales of ~$2million/year). USP’s efforts in Mexico and in other Latin America countries and regions can grow in the coming years with expansion of its tactical programs in accord with USP’s Board Strategic Plan (now in revision). • A FEUM-USP 1999 MOU will be updated to create a work group, which can strengthen and expand ‘Phase 3’ activities. • The efforts of the Pharmacopoeial Working Group of PANDRH have declined, and a new model with new processes are needed to re-invigorate the activity (see notes). • Stakeholder Forum: regulatory and manufacturer representation from surrounding countries were able to attend and support the discussion. This regional stakeholder forum is a first for USP. • The two day First FEUM USP Scientific meeting was attended by about 190 attendees (~100 paying $550 with proceeds to FEUM).

  39. Muchas Gracias

More Related