The 22 nd AHWP Annual Meeting Program The Grand Hotel, Nelson Mandela Road, Vasant Kunj, New Delhi 4-8 December 2017

Transcription

1 The 22 nd AHWP Annual Meeting Program The Grand Hotel, Nelson Mandela Road, Vasant Kunj, New Delhi 4-8 December 2017 Day 1 Agenda: 4 December 2017 (Monday) 08:00-09:10 Hrs Registration of the Delegates TIME (Hrs) INAGURAL SESSION (09:00 10:40) 09:10-09:20 Opening Address Dr. RK Vats, Additional Secretary, Ministry of Health and Family Welfare, Government of India 09:20-09:30 Address Mr. Zamane Abdul Rahman, AHWP Vice Chair, Chief Executive, Medical Device Authority, Ministry of Health Malaysia, Malaysia 09:30-09:40 Address Dr. Henk Bekedam, WHO Representative to India 09:40-09:50 Address Dr. Jagdish Prasad, Director General Health Services, Ministry of Health and Family Welfare, Government of India 09:50-10:00 Address Ms. Preeti Sudan, Secretary, Ministry of Health and Family Welfare, Government of India 10:00-10:10 Address HE Ms. Anupriya Patel, Honourable Minister of State, Health and Family Welfare, Government of India 10:10-10:20 Address HE Mr. Ashwini Kumar Chaubey, Honourable Minister of State, Health and Family Welfare, Government of India 10:20-10:30 Address HE Mr JP Nadda, Honourable Union Minster, Health and Family Welfare, Government of India 10:30-10:35 Vote of Thanks Dr G. N Singh, Drugs Controller General of India, DGHS, Ministry of Health and Family Welfare, Government of India 10:35-11:00 Photo Session & High Tea

2 Day 1 Agenda: 4 December 2017 (Monday) TIME (Hrs) TECHNICAL SESSION I: Overview of Medical Devices Regulation (11:00 13:10) Chairs : Mr. Zamane Abdul Rahman, AHWP Vice Chair, Chief Executive, Medical Device Authority, Ministry of Health Malaysia, Malaysia Sh. Sudhir Kumar, Joint Secretary (Regulation), Ministry of Health and Family Welfare, Government of India :10-11: :10 12:10-12:30 12:30-12:50 12:50-13:10 Co-Chairs : Dr. G.N. Singh, Drugs Controller General (I), CDSCO Dr. S.E Reddy, Joint Drugs Controller (I), CDSCO Speakers: Introductory Remarks Mr. Ali M. Al-Dalaan, TC Chair, AHWP, Executive Director, Medical Devices Sector, Saudi FDA, Kingdom of Saudi Arabia An overview of regulations of Medical Device and IVDs in India (India Regulatory update) Dr. V.G Somani, Joint Drugs Controller (I), CDSCO An overview of regulations of medical devices and IVDs in Singapore (Singapore Regulatory Update) Dr. Rama Sethuraman, Deputy Director, Health Science Authority, Singapore An overview of regulations of medical devices and IVDs in Japan (Japan Regulatory Update ) Mr. Hiroshi YAGINUMA, Director, Office of Regenerative Medicine Product Evaluation Medical Device Evaluation and Licensing Division Pharmaceutical Safety and Environmental Health Bureau, MHLW An overview of regulations of medical devices and IVDs in South Korea (South Korea Regulatory Update) Mr. Seil Park, Assistant Director, Division of High-tech devices, Department of MD evaluation Korea MFDS Mr. Young Wook Ahn, Assistant Director Division of In-vitro Diagnostic Devices Department of MD evaluation An overview of regulations of medical devices and IVDs in Australia (Australia Regulatory Update ) Mr. Michael Flood, Ex-TGA, Locus Consulting Pty Ltd Australia

3 13:10-14:10 Lunch TECHNICAL SESSION II (14:10 15:20) 14:10-14:30 An overview of regulations of medical devices and IVDs in South Africa (South Africa Regulatory Update) Ms. Andrea Julsing Keyter, Deputy Director : Medical Devices, National Department of Health Inspectorate & Law Enforcement Unit, South Africa 14:30-15:00 Medical Device Single Audit Program (MDSAP) The MDASP Experience Mr. Dominik Reterski, VP Quality & Regulatory, Asia Pacific, Medtronic 15:00-15:20 Design controls, Risk Management, Verification and Validation and product release Mr. Fred Viaud, VP Quality & Regulatory, Philips Healthcare TECHNICAL SESSION III (15:20 16:50) 15:20-15:40 Adapting your ISO to the new Requirements 15:40-16:00 Tea Break Mr. Grant Ramaley, Convener, Medical Device Working Group for ISO International Accreditation Forum, Aseptico, Director of Regulatory Affairs 16:00-16:25 16:25-16:50 16:50-17:40 TECHNICAL SESSION III (Continue) Role of Technical Standards and updates on international technical standards Dr. Peter Linders, Director, Standards & Regulations, Regulatory Standards, Philips Healthcare Clinical Trial Environment - Australia Dr. Catherine Bourgeois, Vice President, Field Clinical Affairs, Emerging Markets & ANZ, Abbott PANEL DISCUSSION I (16:50-17:40) Accessibility, Affordability of Medical Devices and Safeguards of Consumer Rights Moderator: Mr. Pavan Choudhary, Director General and Chairman of MTaI Speakers: Ms. Jaishree Gupta, Consumer Online Foundation, New Delhi Dr. V. G. Somani, Joint Drugs Controller, CDSCO Dr. Madhur Gupta, Technical Officer Pharmaceuticals, WHO, Country office for India Ms. Manisha Sridhar, Regional Advisor, WHO SEAR office India Dr. Y. K Gupta, Prof. & Head Dept. of Pharmacology, AIIMS New Delhi Ms. Leena Menghaney, Head South Asia, Access Campaign, Medecins Sans

4 17:40-17:50 Closing Remarks Frontieres, India Mr. Himanshu Baid, MD, Poly Medicure Limited, India Dr. Jeong-Rim Lee, TC Co-Chair, Director, Cardiovascular Devices Division,Department of MD evaluation, Ministry of Food and Drug Safety (MFDS) CULTURAL EVENING FOLLOWED BY GALA DINNER BY INVITATION (18:30 ONWARDS): END OF DAY 1

5 Day 2 Agenda: 5 December 2017 (Tuesday) TIME (Hrs) TECHNICAL SESSION IV: AHWP Playbook Training Workshop (9:00-10:40) 09:00-09:10 Welcome speech Technical Committee Capacity Building Program Ms. Tran Quan, Capacity Building Team Leader, VP, Regulatory Affairs, Asia Pacific Medical Technology Association (APACMed), Laos PDR Opening Speech Play Book Training Session Mr. Ali M. Al-Dalaan, (TC Chair, AHWP), Executive Director, Medical Devices Sector Saudi Food & Drug Authority, Kingdom of Saudi Arabia Introduction of the 2 Day Training Program Ms. Joanna Koh, AHWP PB Program Co-ordinator & Lead Trainer, Principal Consultant MDnet Regulatory Consultants, Singapore 09: Preparatory steps to MD Controls ASEAN experience / Centering on the AMDD elements Mr. Zamane Abdul Rahman Chief Executive, Medical Device Authority, Ministry of Health Malaysia :40 Takes 2 to Tango CSDT/EP and standards 10:40-11:00 Tea Break Mr. Seet Wing Gang, Head Regulatory Intelligence, Greater Asia, Becton Dickinson 11:00-11:40 11:40-12:20 12:20-13:00 TECHNICAL SESSION V (11:00-13:00) Classification Rules GMD/IVD D Why The Rules? Is there an alternative? Mr. Greg LeBlanc, M.Sc., RAC, Director, Regulatory Affairs and Quality Systems, Cook (Canada) Inc. CAB Role and Grouping A balance between Regulatory Controls and Processes with the Economics of MD Industry Dr. Vincent Lam, MHS Manager and Senior Product Specialist, TUV SUD Product Service Objectives and limitations: In-country Lab Testing Dr. G. Kalyan Varma, VP, Global Business Field-Electrical, Business Stream Products-IMEA, TUV Rheinland Mr. Petra Kaars-Wiele, Senior Director Regulatory, Quality & Labelling, Abbott Diagnostics

6 13:00-14:00 Lunch TECHNICAL SESSION VI (14:00-14:50) 14:00-14:25 Clinical Investigation and evaluation for Medical Devices: Regulator perspective Dr. Mijung Son, Regulator (MFDS) Korea 14:25-14:50 Clinical Investigation and evaluation for Medical Devices: Regulator perspective Mr. Arthur Brandwood, Brandwood Biomedical, Founder and Principal Consultant PANEL DISCUSSION II (14:50-15:40) 14:50-15:40 Clinical Investigations and Real World Evidence Moderator: Ms. Sumati Randeo Director Global Strategy Regulatory Affairs & Advocacy Abbott Laboratories Panellists: 15:40-16:00 Tea Break Ms. Katy Peterson, Director, Global RA Boston Scientific Ms. Kate Hyeong Joo Kim Director, Regulatory Strategy & Innovation, ASPAC Director Regulatory Affairs, North Asia, Johnson & Johnson Medical, Republic of Korea Mr. Kwan Han Ong, Regional Associate Director, Clinical Affairs, Asia Pacific Regional Associate Director, Regulatory Affairs, APAC Dr. VG Somani, Joint Drugs Controller (I), CDSCO PANEL DISCUSSION III (16:00-16:40) 16:00-16:40 Regional Agreements, Challenges (TRIPS Agreement) and access to Medical Device Provisions In TRIPS Moderator: Mr. Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) Panellists: Dr. VG Somani, Joint Drugs Controller (I), CDSCO Dr. S.B. Sinha, Advisor, Healthcare Technology, National Health Systems Resource Centre, New Delhi Dr. Anand Grover, Senior Advocate, Supreme Court of India, the Director of the HIV/AIDS Unit of Lawyer s Collective (India) Ms. Aradhana Johri, Former Secretary Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers; Secretary of Finance (Disinvestment); Former Additional Secretary, Ministry of

7 Health and Family Welfare, Government of India TECHNICAL SESSION VII (16:40-17:20) 16:40-17:00 Performance evaluation of IVD regulation Dr. Benny Ons, Director of Regulatory Affairs at BD Diagnostics and BD Biosciences Europe, Becton Dickinson International Becton Dickinson B.V. 17:20-17:30 Closing Remarks Ms. Joanna Koh, AHWP PB Program Co-ordinator & Lead Trainer, Principal Consultant MDnet Regulatory Consultants, Singapore 17:00-17:20 Liaison Member Updates: (i) GS1 Updates (ii) UDI Databases: Useful Tools for Regulatory Controls. How to utilize them in the MD Life Cycle especially in referencing for Pre Market Assessments Ms. Ulrike Kreysa, VP, Healthcare, GS1 Global Office END OF DAY 2

8 Day 3 Agenda: 6 December 2017 (Wednesday) TIME (Hrs) TECHNICAL SESSION VIII: AHWP Technical Committee Meeting (9:00-10:40) 09:00-09:10 Recap of Play Book session 1 and introduction of session 2 09:10-09:55 Ms. Joanna Koh, Principal Consultant, MDnet Regulatory Consultants, Singapore Post Market - Medical Device Post market for Digital Healthcare: Cybersecurity prevention for MDs Mr. John Ramesh, MD, TUV Rheinland LLC, Oman & Regional Field Manager, Business Solutions, IMEA & APAC 09:55-10:40 Post Market - A Growing Global Concern: Counterfeit Medical Devices 10:40-11:00 Tea Break Dr. Nazeeh S. Alothmany, Vice Executive President, Medical Device Sector, Saudi FDA, KSA TECHNICAL SESSION IX (11:00-11:30) 11:00-11:30 Advertisement and Labelling Mr. Er Alfred Kwek, Director, Public Affairs, Edwards Life Sciences S PL PANEL DISCUSSION IV (11:30-12:15) 11:30-12:00 Play Book intiatives and Road ahead Moderator: Mr. Scott Sanderson, 3M Health Care, International Regulatory Affairs and Quality Compliance Leader, Medical Division, Minnesota Panellists: Dr. Arianti Anaya, Director of Medical Devices and Household Health Pdts Evaluation, MOH, Indonesia Ms. Agnes Sitta Kijo, Manager, Medical Devices; Diagnostics Registration, Tanzania Food & Drugs Authority Mr. Grant Ramaley, Aseptico, Director of Regulatory Affairs 12:00-12:15 Closing of AHWP PlayBook Training Program for the Current Cycle Ms. Joanna Koh, AHWP PB Program Co-ordinator & Lead Trainer, Principal Consultant MDnet Regulatory Consultants, Singapore TECHNICAL SESSION X: AHWP Technical Committee (TC) Workshop (12:15 13:00)

9 12:15-13:00 Device & Operation Risks of Tele-medicine and e-health: Regulatory Consideration across Jurisdictions 13:00-14:00 Lunch Ms. Ann Graves, VP, International Regulatory Affairs, Abbott TECHNICAL SESSION XI (14:00 15:00) 1400:-14:30 Regulatory on Medical Devices using 3D Printing From Manufacturing to AE Reporting (e.g. QMS, QMS audit, pre-market submissions, clinical trial, AE reporting and recall) Dr. Jang Yong Choi, Deputy Director, Division of Medical Device Safety Evaluation Medical Device Safety Bureau, Ministry of Food and Drug Safety (MFDS) 14:30-15:00 Diagnostic Devices based on AI and Big Data Analytics Thoughts on Validation and Risk Management Ms. Nicole Taylor Smith, Senior Director, Global Regulatory Affairs Policy & Intelligence, Johnson & Johnson PANEL DISCUSSION V (15:00-15:40) 15:00-15:40 Panel discussion: Challenges and issues to regulate an innovative medical devices: Barriers and Enablers to development Moderator: Ms. Miang Tanakasemsub, Head, Regulatory Affairs (Asia & Russia), Alcon Panellists: Dr. S. Eswara Reddy, Joint Drugs Controller(I), CDSCO Dr. Manisha Sridhar, Regional Advisor, WHO SEAR office India Representative from Department of Electronics & Information Technology (DeITY) Representative from Quality Council of India Ms. Kirti Arora, Associate Director, Regulatory and Quality, Boston Scientific India Mr. Matthew Hein, Senior International Trade Specialist, Industry & Analysis, U.S. Department of Commerce International Trade Administration, Office of Health and Information Technologies 15:40-16:00 Tea Break PARALLEL SESSIONS (16:00-18:00) PARALLEL SESSION - I : AHWP TC Workshop Session - HALL 1

10 16:00-16:25 Changing global regulatory environment opportunity and threat in industry - focused on premarket Mr. Jeongpyo Hong, Manager, Regulatory Affairs, Health & Medical Equipment Business, Samsung Electronics 16:25-16:50 Pre- market approval Essential Principles for safety, quality and performance Mr. Michael Flood, Principal, Locus Consulting Pty Ltd 16:50-17:15 Use of Real World Evidence in clinical and regulatory decision from Industry experience Dr. Justin Yoo, Government Affairs, Health Economics & Reimbursement, Manager Corporate Relations, Ambassador, St. Jude Medical Korea YH, Abbott 17:15-17:40 Post-market control of medical devices-how far we have gone towards harmonization Ms. Jennifer MAK Kit-shu, Senior Electronics Engineer (Medical Device Control Office), Department of Health, Medical Device Control Office, Department of Health, Hong Kong China 17:40-17:50 TGA Reforms for Medical Devices & IVDs and Clinical trial landscape in major countries in APAC Ms. Mie Ohama, Principal clinical quality specialist at Medtronic Clinical Research Institute, International quality, Sydney Australia 17:50-18:00 16:00-16:25 Closing Remarks Sh. Aseem Sahu, Dy. Drugs Controller (I), CDSCO Dr. Jeong-Rim Lee, TC Co-Chair, Director, Cardiovascular Devices Division, Department of MD evaluation, Ministry of Food and Drug Safety (MFDS) PARALLEL SESSION -II : India Regulatory Session - HALL 2 (16:00-18:00) Medical Devices Rules, Technical Requirements of manufacture and import of medical devices Sh. Aseem Sahu, Deputy Drugs Controller (I), CDSCO Sh. Sunil Kulshrestha, Assistant Drugs Controller(I), CDSCO 16:25-16:50 Medical Devices Rules, Investigational Medical Devices/new IVD approval Sh. Ravi Kant Sharma, Assistant Drugs Controller(I), CDSCO Sh. Somnath Basu, Assistant Drugs Controller(I), CDSCO 16:50-17:50 Panel Discussion: Opportunities and Way Forward in Manufacturing of Medical Devices (MD)

11 and IVD sector Make in India Program by Invest India (DIPP) Mr. Sanjay Arudi, Senior Director Regulatory Affairs Sustainable Healthcare Solutions, GE Healthcare Mr. R. Asok Kumar, Vice President (QA&RA), Johnson & Johnson Medical, India Mr. Himanshu Baid, MD, Poly Medicure Limited, India Mr. Sudhakar Mairpadi, Director - Quality & Regulatory, Philips Electronics India Limited (Health Care sector) Mr. Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) Dr. V. G. Somani, Joint Drugs Controller (I), CDSCO 17:50-18:00 Q & A and Closing Remarks Dr. V. G. Somani, Joint Drugs Controller (I), CDSCO END OF DAY 3 Day 4 Agenda: 7 December 2017 (Thursday) TIME (Hrs) 21 st AHWP TC Meeting 09:00-10:40 AHWP TC & WG Leaders Meeting with TC Advisors (Closed Meeting) 10:40-11:00 Tea Break 11:00-11:05 Welcome Speech AHWP & TC & WG Leaders & TC Advisors 11:05-11:25 Opening speech by TC Chair -Roll call by Mr. Bryan So, AHWP Secretariat -Adoption of Agenda by TC Chair -Announcement of the Election Arrangement for Office Bearers of AHWPTC and AHWPTC WGs Mr. Ali M. Al-Dalaan,(TC Chair, AHWP),Executive Director, Medical Devices Sector, Saudi FDA, Kingdom of Saudi Arabia Mr. Bryan So, AHWP Secretariat, Principal Consultant, Smart HealthCare, MedTech and Optics

12 Unit, Hong Kong Productivity Council, Hong Kong SAR, China WORKING GROUP UPDATES (11:25-15:25) 11:25-13:05 (20min each) Working Group 1 Working Group 2 Working Group 3 Working Group 4 Working Group 5 Working Group Chair & Co-chairs 13:05-14:05 Lunch 14:05-15:25 (20min each) Working Group 6 Working Group 7 Working Group 8 STG Working Group Chair & Co-chairs 15:25-15:45 Tea Break 15:45-16:15 Highlight of AHWP PB Training Ms. Joanna Koh, Principal Consultant, MDnet Regulatory Consultants, Singapore 16:15-16:45 Speech by TC Advisors Representative TC Advisor Representative 16:45-16:55 Closing Remarks Mr. Er Alfred Kwek, Director, Public Affairs, Edwards Life Sciences S PL Mr. Ali M. Al-Dalaan, (TC Chair, AHWP), Executive Director, Medical Devices Sector, Saudi FDA, Kingdom of Saudi Arabia GALA DINNER (19:00 ONWARDS): END OF DAY 4

13 Day 5 Agenda: 8 December 2017 (Friday) TIME (Hrs) 21 st AHWP Annual Meeting 09:00-09:30 Speech by officials, Ministry of Health and Family Welfare, Government of India A. Opening Ceremony 09:30-09:45 A. Roll Call B. Congratulation Address C. Opening Speech by AHWP Vice-Chair Mr. Zamane Abdul Rahman, AHWP Vice Chair, Chief Executive, Medical Device Authority, Ministry of Health Malaysia, Malaysia Group Photograph B. Adoption of Agenda C. Adoption of 21st AHWP Annual Meeting Minutes Mr. Zamane Abdul Rahman, AHWP Vice Chair, Chief Executive, Medical Device Authority, Ministry of Health Malaysia, Malaysia Supported by Mr. Bryan So, AHWP Secretariat, Principal Consultant, Smart HealthCare, MedTech and Optics Unit, Hong Kong Productivity Council, Hong Kong SAR, China 09:45-10:15 Updates by AHWP and AHWP TC Ms. Tran Quan, AHWP Vice Chair, Vice President, Regulatory Affairs, Asia Pacific Medical Technology Association (APACMed), Laos PDR Mr. Ali M. Al-Dalaan, (TC Chair, AHWP), Executive Director, Medical Devices Sector, Saudi FDA, Kingdom of Saudi Arabia 10:15-10:30 Announcement of Election Arrangement for Office Bearers of AHWP 10:30-11:00 Tea Break Mr. Bryan So, AHWP Secretariat, Principal Consultant, Smart HealthCare, MedTech and Optics Unit, Hong Kong Productivity Council, Hong Kong SAR, China

14 11:00-12:00 (15min each) AHWP Member Economy updates China - Mr. GAO Guo Biao, Deputy Director General of Medical Device, Registration Department, China Food and Drug Administration, People's Republic of China India - Dr. V. G. Somani, Joint Drugs Controller, CDSCO, India Tanzania - Mr. Mitangu Adam Fimbo, Director of Medicines and Complementary Products., Tanzania FDA APEC -Dr. Arianti Anaya, Director of Medical Devices and Household Health Pdts Evaluation, MOH, Indonesia ASEAN- Mr. Zamane Abdul Rahman, Chief Executive, Medical Device Authority, Ministry of Health Malaysia 12:00-12:30 (10 min each) AHWP Liaison Member Updates APACMed Mr. Fredrik Nyberg, CEO APACMed DITTA Dr. Peter Linders, Director, Standards & Regulations, Regulatory Standards, Philips Healthcare 12:30-13:00 Endorsement of New Member Economies A. Kenya (TBC) To be confirmed by AHWP Endorsement of New Liaison Members GMDN Speech by Representative Mr. Zamane Abdul Rahman, AHWP Vice Chair, Chief Executive, Medical Device Authority, Ministry of Health Malaysia, Malaysia Supported by Mr. Bryan So, AHWP Secretariat, Principal Consultant, Smart HealthCare, MedTech and Optics Unit, Hong Kong Productivity Council, Hong Kong SAR, China

15 13:00-14:15 Lunch 14:15-14:35 Secretariat Updates - Secretariat Report - Financial Report 14:35-14:45 Mr. Bryan So, AHWP Secretariat, Principal Consultant, Smart HealthCare, MedTech and Optics Unit, Hong Kong Productivity Council, Hong Kong SAR, China Resolutions: A. STG change to WG 9 B. Amendment to AHWP TOR/HR C. Participation of WG activities Mr. Zamane Abdul Rahman, AHWP Vice Chair, Chief Executive, Medical Device Authority, Ministry of Health Malaysia, Malaysia Supported by Mr. Bryan So, AHWP Secretariat, Principal Consultant, Smart HealthCare, MedTech and Optics Unit, Hong Kong Productivity Council, Hong Kong SAR, China 14:45-16:00 A. Election of AHWP Leadership of B. Election 16:00-16:30 Tea Break C. Endorsement of Newly Elected Office Bearers of AHWP D. Endorsement of Newly Elected Office Bearers of AHWP TC E. Endorsement of Newly Elected Office Bearers of AHWP TC Working Group Mr. Bryan So, AHWP Secretariat, Principal Consultant, Smart HealthCare, MedTech and Optics Unit, Hong Kong Productivity Council, Hong Kong SAR, China 16:30-16:40 Announcement of 23 rd AHWP Annual Meeting Host Mr. Zamane Abdul Rahman, AHWP Vice Chair, Chief Executive, Medical Device Authority, Ministry of Health Malaysia, Malaysia 16:40 16:50 Speech by Newly Elected Chair of AHW 16:50-17:00 Closing Remarks by Outgoing Chair/Vice-Chair of AHWP Mr. Zamane Abdul Rahman, AHWP Vice Chair, Chief Executive, Medical Device Authority, Ministry of Health Malaysia, Malaysia 17:30-18:00 The 6 th AHWP ASL Annual General Meeting (AGM) ASL Members only

16 (Transfer to another room) END OF DAY 5 <Designs>