1. Networking in Regulatory Capacity Building for Vaccines Catherine Parker: Health Products and Food Branch, Health Canada

2. 2 New Regulatory Era Growing realization that no single regulatory authority has a monopoly on good science/approaches nor can ‘go it alone’ Closer regulatory cooperation and ‘networking’ a natural response to these realities Inter-agency and country level agreements/ arrangements in turn serve as key instruments that help govern enhanced regulatory interactions

3. 3 International Regulatory Cooperation (IRC) The use of bilateral or multilateral fora to develop best practice, share knowledge, adopt or contribute to international standards, or develop compatible approaches with international counterparts. It can include:  Information sharing  Undertaking collaborative scientific work  Common data collection, risk assessment or compliance methods  Joint or parallel review  Developing common or international standards  Equivalency or Mutual Recognition  Harmonization

4. 4 International Regulatory Cooperation Approach Health Product and Food Branch (HPFB) IRC Approach: 1.Develop and strengthen international relations with key regulatory counterparts and organizations 2.Active collaboration in international standards setting and harmonization initiatives 3.Strategic engagement with countries with emerging regulatory systems

5. 5 1: Partnership with Key Regulatory Counterparts and Organizations MOUs with key NRAs (e.g. US FDA, EMA)  Under the MOU, Health Canada has bilateral meetings/teleconferences with US FDA, EMA to further develop collaborative activities and to explore ways to work more effectively and more efficiently and to leverage resources (i.e., expertise, funds, training, etc.) through work- sharing, such as strategic participation at multilateral fora.  Participate in EMA committees and/or working parties (e.g. Biosimilars Working Party, Vaccines Working Party and Biologics Working Party). Consortium with HSA, Swiss Medic, TGA  Meetings of the heads of Medicines Regulatory agencies of Australia, Singapore and Switzerland take place on an annual basis and represent a unique opportunity for senior regulators from around the world to discuss regulatory challenges and develop collaborative solutions

6. 6 2: Collaboration in International Standards Setting and Harmonization Initiatives WHO :  Expert Committee on Biological Standardization of WHO (ECBS)  WHO Blood Regulators Network (BRN)  WHO International Conference on Drug Regulatory Authorities (ICDRA)  WHOCC for Biological Standardization and Evaluation of Biologics Pan-American Network for Drug Regulatory Harmonization (PANDRH)  Biotech Working Group  Vaccines Working Group Laboratory Collaborations:  NIBSC (National Institute for Biological Standards and Control of the UK), in the field of blood product and vaccine testing methodology;  The European Directorate of Quality Medicines (EDQM);  The FDA’s Center for Biologics Evaluation and Research (CBER);  China's National Institute for the Control of Pharmaceutical and Biological Products ( NICPBP) /State Food and Drug Administration (SFDA).

7. 7 3: Strategic Engagement with Countries with Emerging Regulatory Systems HPFB has been involved in several vaccine regulatory capacity building initiatives including:  Vaccine and clinical trial regulation training (e.g. India);  Participation in Pan American Network for Drug Regulatory Harmonization (PANDRH);  African Vaccines Regulatory Forum (AVAREF);  Developing Country Vaccine Regulators’ Network (DCVRN); and  Participating in Workshops on International Regulatory Capacity Enhancement for Influenza Vaccines (WHO and U.S. Department of Health, and Human Services (HHS)

8. 8 Vaccine Regulatory Cooperation & Networking Canadian HIV Vaccine Initiative (CHVI) July 2010, at the XVIII International AIDS Conference in Vienna, Austria, the Government of Canada and the Bill & Melinda Gates Foundation renewed their commitment of up to $139 million to implement the Canadian HIV Vaccine Initiative. Goals To advance the basic science of HIV vaccine discovery and social research in Canada, and low-and-middle-income countries; To support the translation of basic science discoveries into clinical trials, with a focus on accelerating clinical trials in humans; To advance the development of related technologies; To improve the efficacy and effectiveness of HIV Prevention of Mother-to-Child (PMTCT) services in low-and-middle-income countries by determining innovative implementation strategies and programmatic solutions related to enhancing the accessibility, quality, and uptake of HIV PMTCT services; and To address the enabling conditions to facilitate regulatory approval and community preparedness.

9. 9 Vaccine Regulatory Cooperation & Networking Canadian HIV Vaccine Initiative (CHVI) CHVI funding has allowed HPFB to play a greater role in addressing regulatory capacity needs identified by NRAs. Some activities include:  HPFB International Regulatory Forum;  African Vaccines Regulatory Forum (AVAREF);  Training/Information sessions for NRAs provided through participation at vaccine and clinical trial forums and conferences, such as the WHO Pre-qualification Process Workshops (Kenya and Burkina Faso), Satellite Symposiums at AIDS Vaccine Conferences;  CHVI Mentorship Program with the countries of Malawi and Nigeria; and  Development of a road-map for HIV vaccine researchers outlining the vaccine development process in Canada and internationally.

10. 10 Conclusion Enablers to Effective Cooperation: Political and institutional commitment Common approaches (e.g. guidance documents) Transparency and trust (e.g. bilateral and trilateral telecons.) Investment of resources (e.g. HPFB International Regulatory Forum) Mechanics: arrangements (MOUs), virtual networks and secure information platforms Practical, relevant and flexible approaches that result in tangible benefits (e.g. parallel review with Indian NRA) Cooperation at regional and international levels

11. 11 Conclusion Trends and Priorities Growing number of regulatory networks Expansion and linkages between harmonization initiatives (harmonizing approaches, not harmonizing regulations) Pooling of resources/capacity:  Work-sharing  Mutual/unilateral recognition (help to make decisions while respecting context-specific risk management approach) Increasing focus on multilateral initiatives Inspection and post-market surveillance activities.

12. 12 THANK YOU! GRACIAS! MERCI! Catherine Parker Biologics and Genetic Therapies Directorate Health Products and Food Branch, Health Canada Email: cathy.parker@hc-sc.gc.ca Telephone: (001)613-946-0099