Meeting Report GREATER MEKONG SUBREGIONAL WORKSHOP ON REGULATORY ACTIONS TO COUNTER SUBSTANDARD AND FALSIFIED MEDICINES

Transcription

1 Meeting Report GREATER MEKONG SUBREGIONAL WORKSHOP ON REGULATORY ACTIONS TO COUNTER SUBSTANDARD AND FALSIFIED MEDICINES April 2017 Bangkok, Thailand

2 Greater Mekong Subregional Workshop on Regulatory Actions to Counter Substandard and Falsified Medicines April 2017 Bangkok, Thailand

3 WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR THE WESTERN PACIFIC Report Series No. RS/2017/GE/14(PHL) English only MEETING REPORT GREATER MEKONG SUBREGIONAL WORKSHOP ON REGULATORY ACTIONS TO COUNTER SUBSTANDARD AND FALSIFIED MEDICINES Convened by: WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR THE WESTERN PACIFIC WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR SOUTH-EAST ASIA ASIAN DEVELOPMENT BANK Bangkok, Thailand April 2017 Not for sale Printed and distributed by: World Health Organization Regional Office for the Western Pacific Manila, Philippines August 2017

4 NOTE The views expressed in this report are those of the participants of the Greater Mekong Subregional Workshop on Regulatory Actions to Counter Substandard and Falsified Medicines and do not necessarily reflect the policies of the conveners. This report has been prepared by the World Health Organization Regional Office for the Western Pacific for Member States in the Region and for those who participated in the Greater Mekong Subregional Workshop on Regulatory Actions to Counter Substandard and Falsified Medicines in Bangkok, Thailand from 25 to 27 April 2017.

5 CONTENTS SUMMARY INTRODUCTION Meeting organization Meeting objectives PROCEEDINGS Opening session Country presentations and initiatives on regional collaboration Panel discussion on cross-border collaboration Group work: Concrete measures/activities in priority areas for cross-border collaboration CONCLUSIONS AND RECOMMENDATIONS Conclusions Training workshop Recommendations Recommendations for Member States Recommendations for WHO... 6 ANNEXES... 7 Annex 1. List of participants Annex 2. Meeting agenda Annex 3. Presentations Keywords: Counterfeit drugs / Drug and narcotic control legislation & jurisprudence / Fraud / Mekong Valley

6 ABBREVIATIONS ADB AML APLMA ASEAN CoRE GMS SEARN TGA USP Asian Development Bank antimalarial medicine Asia Pacific Leaders Malaria Alliance Association of Southeast Asian Nations Centre of Regulatory Excellence (Singapore) Greater Mekong Subregion South East Asia Regulatory Network Therapeutic Goods Administration (Australia) United States Pharmacopeial Convention

7 SUMMARY Substandard and falsified medicines are a major risk to public health. Substandard and falsified antimalarial medicines (AMLs) are of particular concern in the Greater Mekong Subregion (GMS) because of the spread of drug-resistant malaria. In order to minimize the potential impact of substandard and falsified AMLs and to support the elimination of artemisinin- and multidrug-resistant forms of malaria, there is a need for systematic strengthening of regulatory actions in this area. The World Health Organization (WHO) has taken important steps in addressing the issue by setting up the WHO Member State Mechanism for international collaboration and the Global Surveillance and Monitoring System and by conducting two regional training workshops in Asia and the Pacific in In continuation of the previous training sessions, this workshop, co-organized by the WHO Regional Office for the Western Pacific, WHO Regional Office for South-East Asia and Asian Development Bank (ADB), included a one-day, high-level meeting of heads and senior managers of regulatory agencies in the GMS, followed by a two-day, hands-on practical training of regulatory inspectors and malaria supply chain managers. The objectives of the training were to enhance risk-based, post-market surveillance and inspection of AMLs and other medicines, targeting high-risk areas within the supply chain and cross-border regulatory collaboration that will ultimately support the malaria elimination efforts in the GMS, and to strengthen the regulatory system capacity in general to counter substandard and falsified medicines in the Member States. Partner organizations and the WHO regional offices also provided an overview of their objectives and activities in the regions. During the training workshop for practitioners, WHO headquarters focused on mapping supply chains and importation routes. The meeting also provided opportunities for countries to share challenges and successes in improving quality testing, post-marketing surveillance practices and previous cases of detection of substandard and falsified products in the GMS. 1

8 1. INTRODUCTION 1.1 Meeting organization A Greater Mekong Subregional Workshop on Regulatory Actions to Counter Substandard and Falsified Medicines was held in Bangkok, Thailand from 25 to 27 April The workshop was cosponsored by the Asian Development Bank (ADB) and World Health Organization (WHO) regional offices for South-East Asia and the Western Pacific, and supported by WHO headquarters.it included a one-day, high-level meeting of senior regulators from national regulatory authorities, followed by a two-day, hands-on practical training of regulatory inspectors and malaria supply chain managers. Seventeen participants from Cambodia, India, the Lao People s Democratic Republic, Myanmar, Thailand and Viet Nam attended the meeting. WHO headquarters staff provided a briefing on the global situation to senior regulators and partner organizations active in the Greater Mekong Subregion (GMS) and conducted the hands-on training focused on mapping supply chains and importation routes as well as identifying hotspots. They presented techniques for stakeholder engagement, risk-based inspection and post-marketing surveillance. WHO headquarters staff also advocated cross-border collaboration and the use of WHO reporting tools for the prevention, detection and response strategy to tackling substandard and falsified medical products. Participants from partner organizations were invited as observers and resource persons. They came from the Association of Southeast Asian Nations (ASEAN), United States Pharmacopeial Convention (USP), Australia Department of Health Therapeutic Goods Administration (TGA), Centre of Regulatory Excellence (CoRE) at Duke National University of Singapore Medical School, Asia Pacific Leaders Malaria Alliance (APLMA), South East Asia Regulatory Network (SEARN) and Lao Oxford Mahosot Hospital-Wellcome Trust Research Unit. 1.2 Meeting objectives The objectives of the high-level meeting were: 1) to review and discuss domestic gaps, subregional capacities and vulnerabilities to counter substandard and falsified medicines; 2) to plan concrete national actions to enhance regulatory capacity on prevention, detection and response; and 3) to identify and agree on the implementation of specific cross-border regulatory collaborative actions to minimize cross-border circulation of substandard and falsified medicines. The objectives of the hands-on training workshop were: 1) to strengthen the capacity of national regulators on risk-based surveillance and investigations, inspections and regulatory enforcement actions; 2) to build skills in communication of potential risks to senior management, the general public and neighbouring regulatory authorities; and 3) to build capacity for preventive actions to ensure supply chain integrity. 2

9 2. PROCEEDINGS 2.1 Opening session Dr Klara Tisocki, Regional Adviser on Essential Drugs and Other Medicines, WHO Regional Office for South-East Asia, delivered the opening remarks and welcomed participants to the workshop. In recognition of World Malaria Day (25 April 2017), which had as its theme A push for prevention, she remarked on the dangers of poor-quality and falsified medicines, especially among the most vulnerable: children, poor and marginalized populations. Dr Tisocki identified the interaction between poor-quality and ineffective antimalarial medicines (AMLs) and malaria as one of the leading causes of drug resistance. If AMLs have insufficient potency, then the parasite can rapidly develop resistance to them. She also noted the worrisome spread of non-quality-assured and falsified medicines in South-East Asia and sub-saharan Africa. Dr Tisocki insisted on efforts and improvements to be made in the GMS and urgently called for cross-border collaboration and strengthening of regulatory actions in the region to prevent poor-quality medicines undermining the progress made on malaria elimination and the importance of including safe and quality-assured AMLs, in combination with insecticide bednets and indoor residual spraying, in any effective prevention efforts. Dr Sonalini Khetrapal, Health Specialist, ADB, welcomed participants and introduced ADB s projects for the health sector in the region. The need for strengthening regulatory systems to ensure the quality of antimalarial medical products in the marketplace was emphasized, with ADB working through partners such as WHO, CoRE and the Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit to this end. Following the welcoming remarks, Ms Uhjin Kim, Technical Officer for Pharmaceuticals, WHO Regional Office for the Western Pacific, presented the meeting objectives and the agenda for the meeting. She remarked on the effects of substandard and falsified medicines on patient safety, mistrust in public health systems and contribution to drug resistance, especially in the case of AMLs in the GMS. She pointed out the importance of the meeting to discuss priority actions needed for containment of artemisinin resistance and to reach malaria elimination by Country presentations and initiatives on regional collaboration Thailand recognizes that malaria is an important public health threat in cross-border, rural and forested areas. Although AMLs are not sold in pharmacies, there are illegal sellers in border areas who supply substandard and falsified AMLs. Difficulties in controlling medicines in rural and crossborder areas are increased by the differences in the lists of restricted medicines between countries. Cambodia receives support from the Global Fund to Fight AIDS, Tuberculosis and Malaria to control the quality of medicines and for post-marketing surveillance activities. The presentation pointed out the need for capacity-building in the country, especially in regard to laboratory testing. Myanmar also receives support for quality control from the Global Fund. Dr Thin Zar Thike signalled the difficulties in controlling the smuggling of drugs in cross-border and mountainous areas because of a lack of capacity in rural areas, terrorist presence and growing substandard and falsified medicines market. The national quality control laboratory obtained ISO accreditation in December

10 In the Lao People s Democratic Republic, although the percentage of substandard and falsified products has significantly decreased in the last years, there is a need for improvement in testing, to increase post-marketing surveillance to prevent the availability unlicensed products in the market even after several years as well as to continue vigilance activities and collaboration with the other countries in the region. Viet Nam signalled control of resistance to artemisinin as a priority area and the need for communication and information sharing on substandard and falsified products. Finishing off the session, India presented on a new online drug licensing system in the State of Madhya Pradesh that will be used to ease the application and evaluation processes for new licences for drug manufacturers and retailers. At the central level, the Central Drugs Standard Control Organization (CDSCO) has also developed an online drug licensing system, SUGAM, for the application, processing and granting of new permission by the central drug regulatory authority. 2.3 Panel discussion on cross-border collaboration A panel discussion on cross-border collaboration was led by Mr Gerald Heddell, Director, Inspection, Enforcement and Standards of the Medicines and Healthcare Products Regulatory Agency, with the participation of high-level representatives from five GMS countries: Mr Hean Kimseat from Cambodia, Dr Lamphone Syhakhang from the Lao People s Democratic Republic, Dr Thin Zar from Myanmar, Mr Sombat Hirunsupachote from Thailand and Ms Nguyen Thi Thu Thuy from Viet Nam. The objective for the discussion was to identify the top three priorities in cross-border collaboration. Dr Heddell shared experiences and results from the collaboration among countries within the European Medicines Agency network. Delegates agreed on the difficulties to control medicines in rural, cross-border and forested areas where there is a presence of mobile populations and informal vendors and where there is higher incidence of malaria. They shared common challenges such as the lack of financial and human resources; the need for capacity-building, especially in the field of laboratory testing and investigation; and the need for better coordination with law enforcement institutions at the country level. Some of the countries already collaborate at national and provincial levels and have signed bilateral memorandums of understanding. However, the discussants agreed on the need for more collaboration and the development of a regulatory framework in the GMS. 2.4 Group work: Concrete measures/activities in priority areas for cross-border collaboration Countries were divided into three groups and identified priority actions for cross-border collaboration in the future. The group work was moderated by Ms Lucky S Slamet, Former Head of the Indonesia National Agency of Food and Drug Control. 3.1 Conclusions 3. CONCLUSIONS AND RECOMMENDATIONS As per the results of post-marketing surveillance data shared by the Member States in the GMS, countries such as Cambodia and the Lao People s Democratic Republic had experienced a substantial decline in the number of falsified products detected in their countries, but Myanmar still faces 4

11 challenges in controlling poor-quality products. There was an agreement among senior regulators at the workshop that some cross-border areas between countries are vulnerable and are at risk of being infiltrated by substandard and falsified medicines. The common challenges and issues faced by the countries are: limited number of inspectors to investigate and monitor formal and informal markets; insufficient laboratory capacity for quick turnaround of testing; and lack of coordination with other regulatory enforcement institutions such as police and customs in vulnerable areas such as hard-to-reach, mountainous and/or border areas. Despite existing mechanisms such as ASEAN, there are limited multilateral and bilateral discussions. There is no umbrella framework for regulatory collaboration in the GMS. Some countries have taken the initiative to sign bilateral memorandums of understanding, but they are time-consuming and may not be efficient as numerous bilateral agreements are then needed to cover all six GMS countries: Cambodia, China, the Lao People s Democratic Republic, Myanmar, Thailand and Viet Nam. The discussion focused on priority areas to enhance cross-border collaboration and to identify key potential regulatory actions needed to eliminate poor-quality medicines. The three priority areas are: 1) post-marketing monitoring of quality and safety; 2) regulatory capacity strengthening at the provincial level; and 3) information sharing on detected substandard and falsified medicines and any product that was withdrawn or recalled from the markets. The meeting also provided an opportunity for participants to discuss and share ongoing activities with the development partners involved in malaria elimination in the GMS (USP, TGA, Lao Oxford Mahosot Hospital-Wellcome Trust Research Unit, APLMA and CoRE at Duke National University of Singapore Medical School). The speed networking session also provided opportunities for participants to discuss bilateral issues and potential joint activities Training workshop Participants mapped the supply chain route of imported products from neighbouring countries, identified areas of high incidence of malaria and artemisinin resistance, and pinpointed at-risk ports of entry for substandard and falsified medicines along the borders. It was acknowledged that collaboration and information sharing between provincial authorities along the high-risk port areas are important. This was followed by a discussion on awareness raising among all stakeholders such as police, customs, health workers, communities and the private sector. The participants received training on stakeholder engagement, risk-based investigation and inspection, and risk communication. The Lao Oxford Mahosot Hospital-Wellcome Trust Research Unit presented their ADB-funded project to identify and compare the latest screening and field detection devices for medicines quality assessment. Further research is needed to identify cost-effective devices that are appropriate for country situations. USP conducted training on sampling and testing. Participants acknowledged the importance of information sharing and collaboration in post-marketing surveillance as duplication of efforts would be an inefficient way of utilizing limited resources for regulation. 5

12 3.2 Recommendations Recommendations for Member States Member States are encouraged to do the following: 1) to strengthen post-marketing surveillance to monitor the quality and safety of products in the market; 2) to strengthen the regulatory capacity at the provincial level and to promote coordination and collaboration with other enforcement agencies such as police and customs; 3) to share information with neighbouring countries in the GMS on substandard and falsified products detected and any products withdrawn or recalled from the market; and 4) to promote reporting to the WHO Rapid Alert System to help and alert other Member States Recommendations for WHO WHO is requested to do the following: 1) to reflect the suggestions from Member States into Global Fund Regional Artemisininresistance Initiative (RAI-2) malaria pharmaceutical activities to support Member States in strengthening regulatory capacity; 2) to support Member States to organize bilateral cross-border workshops in provinces along country borders to strengthen regulatory capacity, collaboration and information sharing; and 3) to strengthen the capacity of Member States in regulatory enforcement actions on manufacturers, wholesalers, distributors and retailers to tackle poor-quality products. 6

13 ANNEXES Annex 1: List of participants CAMBODIA Mr Hean Kimseat: Vice Chief of Regulation Bureau, Department of Drugs and Food, Ministry of Health, Phnom Penh, Mr Sea Thol: Chief of Essential Drug Bureau, Department of Drugs and Food, Ministry of Health, Phnom Penh, Mr Ouk Rada: Logistic Manager. National Center for Entomology, Parasitology and Malaria Control, Phnom Penh, INDIA Dr Naresh Sharma: Assistant Drugs Controller (I), Office of Controller, Food and Drug Administration, Mr Shobhit Koshta: Deputy Drug Controller, Office of Controller, Food and Drug Administration, LAO PEOPLE'S DEMOCRATIC REPUBLIC Dr Lamphone Syhakhang: Deputy Director, Food and Drug Department, Ministry of Health Vientiane, Dr Bounxou Keohavong: Deputy Director, Food and Drug Department, Ministry of Health, Vientiane, Dr Simone Nambanya: Deputy Director, Centre of Malariology, Parasitology and Entomology (CMPE), Ministry of Health, Vientiane, MYANMAR Dr Thin Zar Thike: Deputy Director (Drug Control), Department of Food and Drug Administration, Nay Pyi Taw, Tel: , Ms Zune Lay New: Pharmacist (Regional Inspector, Drug Control Section, Department of Food and Drug Administration, Yangon, Tel: ; , Ms Aye Thet Hnin: Pharmacist (Regional Inspector), Drug Control Section, Department of Food and Drug Administration, Mandalay, Tel: ; , THAILAND Mr Sombat Hirunsupachote: Pharmacist, Senior Professional Level Inspectorate Unit, Division of Post-marketing Control, Bureau of Drug Control, Food and Drug Administration, Ministry of Public Health, Tel: (662) , Fax: (662) , 7

14 Ms Sansanee Rojanapanus: Public Health Technical Officer, Professional Level, Bureau of Vector Borne Diseases, Department of Disease Control, Ministry of Public Health, Tel: (662) , Fax: (662) , Mr Sermrat Chaiyakun: Pharmacist, Professional Level, Inspectorate Unit, Division of Postmarketing Control, Bureau of Drug Control, Food and Drug Administration, Ministry of Public Health, Tel: (662) , Fax: (662) , VIET NAM Ms Nguyen Thi Thu Thuy: Deputy Head, Drug Registration Division, Drug Administration of Viet Nam, Hanoi, Dr Bui Quang Phuc: Head of the Department of Malaria, Research and Treatment National Institute of Malariology, Parasitology and Entomology (NIMPE), Hanoi, Ms Hoang Thanh Mai: Deputy Head of Drug Information and Advertising Management Divisio, Drug Administration of Viet Nam, Hanoi, TEMPORARY ADVISERS Mr Gerald Heddell: Director of Inspection, Enforcement and Standards, Medicines and Healthcare products, Regulatory Agency (MHRA), London, Ms Lucky S Slamet: Former Head, National Agency of Food, and Drug Control (NAFDC), Jakarta, luckyslamet2002@yahoo.com RESOURCE PERSONS Dr Paul Newton: Professor of Tropical Medicine, Director of Lao-Oxford-Mahosot Hospital- Wellcome Trust Research Unit (LOMWRU), Mahosot Hospital, Vientiane, paul.newton@tropmedres.ac Dr Celine Caillet: Scientific Coordinator and Senior Scientist, Lao-Oxford-Mahosot Hospital- Wellcome Trust Research Unit (LOMWRU), Mahosot Hospital, Vientiane. celine.caillet@iddo.org; celine.caillet@wwarn.org OBSERVERS Asian Development Bank Dr Douglas Ball: ADB Regulatory Consultant, Asian Development Bank, 6 ADB Avenue, Ortigas Center, Mandaluyong, dball.consultant@adb.org Dr Sonalini Khetrapal: Health Specialist, Asian Development Bank, 6 ADB Avenue, Ortigas Center, Mandaluyong, skhetrapal@adb.org Ms Editha Santos: RMTF Consultant (Finance/TA Administration), SDCC (Health Sector), Asian Development Bank, 6 ADB Avenue, Ortigas Center, Mandaluyong esantos.consultant@adb.org 8

15 Mr Valerio Reggi: ADB Regulatory Consultant, Asian Development Bank, Myanmar, Asia Pacific Leaders Malaria Alliance Dr Geoff Clark: Senior Strategic Health Adviser (Access), Asia Pacific Leaders Malaria Alliance, #04-01 Helios, 11 Biopolis Way, Singapore , Singapore, Ms Marie Lamy: Senior Associate Services & Commodities (Access), Asia Pacific Leaders Malaria Alliance #04-01 Helios, 11 Biopolis Way, Singapore , Singapore. Mr Paul Lalvani: Senior Advisor on Access, Asia Pacific Leaders Malaria Alliance, #04-01 Helios, 11 Biopolis Way, Singapore , Tel: , Centre of Regulatory Excellence Prof John CW Lim: Executive Director, Centre of Regulatory Excellence, Duke-NUS Medical School (CoRE), Singapore, Prof James Leong: Assistant Professor, Head of Education, Centre of Regulatory Excellence, Duke- NUS Medical School (CoRE), Singapore, United States Pharmacopeial Convention Dr Souly Phanouvong: Senior Manager, Asia Programs, Promoting the Quality of Medicines (PQM), Global Health Impact Programs (GHIP), United States Pharmacopeial Convention, Rockville, MD , United States of America, Fax (1-301) , Therapeutic Goods Administration Mr Mina Mounir: Director (Principal Evaluator), Cardiovascular & Analgesic Drugs, Therapeutic Goods Administration, Canberra, Australia, SECRETARIAT WHO Regional Office for South-East Asia Dr Klara Tisocki: Regional Adviser (EDM), Essential Drugs and Other Medicines, Department of Health Systems Development, WHO Regional Office for South-East Asia, Indraprastha Estate, New Delhi , India, Tel: , Fax: , Dr Manisha Shridhar: Regional Advisor, Intellectual Property Rights, Trade & Health, Department of Health Systems Development, WHO Regional Office for South-East Asia, Indraprastha Estate, New Delhi , India, Tel: , Fax: , Dr Madhur Gupta: Technical Officer- Pharmaceuticals, Office of the WHO Representative to India, RK Khanna Tennis Stadium, Safdarjung Enclave, Africa Avenue, New Delhi , India, Phone : , Mobile : Fax : , guptamadh@who.int 9

16 Mr Liviu Vedrasco: Technical Officer, WHO Country Office Thailand, 88/20 Permanent Secretary Building Ministry of Public Health Tiwanon Road Nonthaburi, Thailand, vedrascol@who.int WHO Regional Office for the Western Pacific Ms Uhjin Kim (Responsible Officer): Technical Officer, Essential Medicines and Health Technologies, World Health Organization, Regional Office for the Western Pacific United Nations Avenue, 1000 Manila, Tel no.: , kimu@who.int Ms Eva Mata: Consultant, Essential Medicines and Health Technologies, World Health Organization, Regional Office for the Western Pacific, United Nations Avenue 1000 Manila, matae@who.int WHO headquarters Mr Michael Deats: Group Lead, SSFFC Surveillance and Monitoring, Safety and Vigilance, Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland, Office: , Mobile: , deatsm@who.int Ms Pernette Bourdillon-Esteve: Analyst, SSFFC Surveillance and Monitoring, Safety and Vigilance, Essential Medicines and Health Products, World Health Organization Geneva, Switzerland, bourdillonestevep@who.int 10

17 Annex 2: Meeting agenda High-level meeting 1 st day Tuesday 25 April :00 Registration 09:00 09:15 Opening Speech from SEARO RD Dr Klara Tisocki WHO SEARO Welcome remarks Dr Sonalini Khetrapal ADB 09:15 09:25 Participant introduction All 09:25 09:30 Workshop objectives Ms Uhjin Kim WHO WPRO 09:30 09:45 Group photo All 09:45 10:00 Morning tea 10:00 10:30 Substandard and Falsified Medical Products: a global Mr Michael Deats 10:30 11:00 update Impact of substandard and falsified medicines in the Mekong Region Regulatory actions in the GMS Current progress and approaches to counter SF medical products 11:00 12:30 o Cambodia o Lao People s Democratic Republic o Myanmar o Thailand o Viet Nam o India 12:30 12:45 Discussion 12:45 13:45 Lunch Initiatives on regional collaboration o ASEAN o USP o APLMA 13:45 14:30 o TGA o CoRE o APEC o SEARN Panel discussion on cross-border collaboration Existing mechanisms Benefits 14:30 15:30 Barriers Output: identification of top 3 priority areas for crossborder collaboration 15:30 15:45 Afternoon tea Group work Concrete measures/ activities in priority areas for crossborder collaboration in :45 16:45 WHO, WHAT, WHEN, HOW 16:45 17:15 Plenary Feedback from the groups WHO HQ Prof Paul Newton Lao-Oxford-Mahosot 15 mins each 5 mins each Facilitator: Mr Gerald Heddell Panel Members: Head of NRAs from GMS 3 groups 10 minutes each 17:15 17:45 Speed Networking - Strengthening bilateral communications 11 All Member States

18 17:45 17:50 Closure 18:00 19:00 Welcome reception at Mondo Terrace Training sessions 2 nd and 3 rd day Wednesday 26 April :00 09:15 Training Workshop Objectives Mr Michael Deats, WHO HQ 09:15 10:30 Exercise. All Mapping the Regional Supply routes for medicines Country input on routes and types of importation of medicines How do substandard and falsified medicines enter the supply chain 10:30 11:00 Morning Tea 11:00 11:30 Discussion. Using all available data to identify risk hotspots All 11:30 12:00 Discussion. Stakeholder engagement All 12:00 13:00 Best use of limited resources Mr Gerald Heddell Risk based post-market surveillance MHRA, UK Risk based inspection 13:00 14:00 Lunch 14:00 14:30 Conducting Market Surveys All 14:30 15:30 Discussion Planning Cross-border cooperation and country and activities Communication and collaboration between NRAs to strengthen national enforcement actions/ recalls 15:30 16:00 Afternoon Tea 16:00 17:00 Exercise Seizure of suspected falsified medicines at border crossing Dr Lucky Slamet and all delegates All Thursday 27 April :00 09:45 Screening and Field Detection devices Celine Caillet Lao-Oxford-Mahosot Hospital 09:45 10:30 Laboratory Practice Souly Phanouvong Testing Methodologies United States Interpreting Laboratory reports Pharmacopiea Submission of samples to laboratory Access to laboratories, nationally / regionally 12

19 10:30 11:00 Morning Tea 11:00 12:00 Using WHO tools Global Surveillance and Monitoring System Portal, Search tool and reporting 12:00 13:00 Discussion: Risk Communication National/ Regional/ International Practice WHO and ASEAN Rapid Alerts Recalls, National Experiences 13:00 14:00 Lunch 14:00 15:00 Discussion: Investigation, Enforcement and Sanctions Country experience Legislation Use of sanctions Mr Michael Deats Mrs Bourdillon-Esteve WHO HQ Mr Michael Deats Mrs Bourdillon-Esteve WHO HQ Mr Michael Deats Mrs Bourdillon-Esteve WHO HQ 15:00 15:30 Prevention, Detection, and Response Mr Michael Deats Mrs Bourdillon-Esteve WHO HQ 15:30 15:45 Afternoon Tea 15:45 16:30 Presentation of Certificates and Closure WHO 13

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