A SHARING ON REGULATORY TRAINING EXPERIENCE IN ASIA JACK WONG

Transcription

1 A SHARING ON REGULATORY TRAINING EXPERIENCE IN ASIA JACK WONG

2 Jack Wong Director, Regulatory Affairs, Asia Pacific, TerumoBCT Mobile: Profession Summary: Over 19 years of Regulatory, Clinical Trial and Pharmacovigilence experience in Asia with good knowledge in the field of Medical Devices, Pharmaceuticals, Nutritional, Consumer Healthcare and Biological products Externally, playing a leading role among all the Regional Regulatory professionals in AHWP (Asian Harmonization Working Party), and was invited to provide regulatory training to local universities and industry organizations. Prof Wong also very active in ASEAN, APEC, ISO and WHO projects In his professional career, Prof Wong developed the First Asia Regulatory Affairs Certificate since 2007 with more than 1400 students in alumni. He is also founder of ARPA (Asia Regulatory Professional Associations) since 2010 with more than 1200 members and Asia GRP (Good Regulatory Practice) Research Centre since 2011 with more than 10 companies supporting. The First Asia Regulatory Book was launched in May

3

4 About ARPA Established 1 Jan 2010 The Asia Regulatory Professional Association (ARPA) is an organization of Healthcare Regulatory Affairs professionals in Asia. ARPA aims to raise the standard and social recognition of Regulatory Professionals as part of Healthcare team. ARPA website (Support by Healthcare Federation) hk/e_doctors/health2.asp x?id=1

5 Structure Chair - Dr Saleh S. Al-Tayyar from SaudiFDA Co-chair - Madam Liu Li-Ling from TaiwanFDA. Dr Saleh and Madam Liu are also the chair and co-chair in Asia Harmonisation Working Party (AHWP) to help avoid duplication with relevant work that is ongoing within that organization which aims to work towards greater harmonization in medical device regulations in Asia. Prof. Rosanna Peeling is advisor (ex-who staff, now working in London University). Prof. Herbert Voigt (IFMBE, International Fed of Medical and Biological Engineering) WHO Contact point: Dr. Edward Kelley (Paitent Safety, WHO) Prof. Jack Wong is founder and secretary (external) Jacky Kwan is secretary (internal)

6 Structure Hong Kong Regulatory Affairs Academy Prof Raymond Tong Department of Health Technology and Informatics Hong Kong Polytechnic University Singapore Regulatory Affairs Academy Prof Teoh Swee-Hin Head Bioengineering, School of Chemical and Biomedical Engineering NanYang Technological University Taiwan Regulatory Affairs Academy Ms Liu Li Ling Director Division of Medical Devices and Cosmetics Taiwan Food and Drug Administration (TaiwanFDA) Dr Chi-Ming Chiou Medical and Pharmaceutical Industry Technology and Development Center (PITDC) Vietnam Regulatory Affairs Academy Mr Nguyen Minh Tuan Director General Department of Medical Equipment and Construction Ministry of Health

7 Structure India Regulatory Affairs Academy Dr Ravi Kant Sharma Assist Drug Controller (I) Central Drugs Standard Control Organization Ministry of Health and Family Welfare India Thailand Regulatory Affairs Academy Prof Teoh Swee-Hin Head Bioengineering, School of Chemical and Biomedical Engineering NanYang Technological University Philippines Regulatory Affairs Academy Agnette Peralta Director Center for Device Regulation, Radiation Health and Research, Food and Drug Administration Department of Health Philippines South Africa Regulatory Affairs Academy Debjani Mueller University of the Witwatersrand South Africa

8 Membership Joining Asia Regulatory Professional Association (ARPA) is FREE of charge. We intended to gather anyone who interest in Asia regulatory affairs issue. To become members, just registered in LinkedIn group of ARPA-Asia Regulatory Professional Association. We have > 2000 members registered

9 5 core-activities

10 Education

11 Education - Universities

12 Education Exam Panel Chair Prof Raymond Tong Edward Yau Carmen Septon Jacky Kwan Stephan Lam David Chan Tony Chow Lawrence Yiu Jack Wong

13 13 Education - ThaiFDA

14 14 Education - TaiwanFDA

15 Education Malaysia MDA ( MEDICAL DEVICE AUTHORITY)

16 Education RA Alumni Failitators Jack Wong, Jacky Kwan Facilitators Dr. Erin Jack Teo Wong, (Advisor) Jacky Kwan Aaron Kwok - - Chair Johan Johan Wang. Wang. Shu-Kan Nieh, Nieh, Irene Irene Lu Lu (Co-Chair) Dr Timothy Tan Dr. Yiu Yuchun, Dr. Yiu Yuchun, Mr. Lim Jing Mr. Lim Jing (Co-Chair) (Co-Chair) Taiwan 16 HK Taiwan Singapore

17 Objectives Education RA Alumni Increase awareness of RA Build network among RA RA job database sharing Share RA and Clinical trial knowledge Yearly guest speaker and site visit Pool for future Regulatory Academy, RA Master Program and RA fellowship development

18 Publication

19 Publications Regulatory Textbook - To develop the professional, the very first Asia Regulatory textbook was developed - Name of book: Handbook of Medical Device Regulatory Affairs in Asia - We got support and writers from the following organisations to write the book AHWP, WHO, US FDA, EU, Japan PMDA etc - The book was released on May Table of content - Student price US$49 (Amazon price: US$149.95) ARPA Journal - A professional journal was developed - 3 issues was released - We are in the phase of inviting Editorial Committee - Free download

20 Forum

21 Forum HK Forum / LRP Panel The LRP Panel meeting is a regular meeting and opens to all companies or individuals to provide a free of charge and interactive platform to share the latest regional and global requirements in medical devices. The objectives of the LRP panel meeting are: Providing Asian Harmonization Working Party (AHWP) updates by industry (non-governmental organization) and government representatives. Maintaining a regular gathering of regulatory and non-regulatory staff in medical device fields. Creating a platform for different trade associations, industries and the government (Department of Health) to discuss and updates the medical device regulatory development (especially in Hong Kong and Asia). Providing more information on the functions of Local Responsible Persons. Facilitating education in regulatory professionals for university students. Providing a discussion platform on product recalls and product listing in the Medical Device Administrative Control System (MDACS) in Hong Kong. Secretary: Tammy Tam Company Confidential

22 Standard

23 Standard GRP Research Centre Good Regulatory Practice Research Centre With support of China Food and Drug College ( 廣東食品藥品職業學院 ), a GRP Research Centre was established to support research on Good Regulatory Practice

24 Standard RA Consultancy Academy Global RA Consultancy Academy Objectives This group aims to raise and set standard of Regulatory function (in both RA department in a company and RA consultancy). One of key projects is developing a RA department standard or guidance document to explain what is a good quality system to manage RA work in Regulatory function ( I have invited BSI and SGS to assist on this initiative as well) Team Yanira Galván (IsaHealth), William Ku (emergogroup), Arkan Zwick (Croma), Toni Jorgenson (MDRAC); Eric Verstegen; May Ng (Biosensors) Secretary Jack Wong

25 Standard Guideline on Good Regulatory Practice Objective(s) of the proposed project: Create a forum for discussion and training, in order to facilitate information exchange and improve the understanding of GRP Help regulators and industries to establish and perfect their quality system on regulatory departments world widely Supporting organization: World Health Organization (WHO) Proposed project team: Project coordinator: Adriana Velazquez Berumen Project members: People from WHO (e.g. Peng Si), academia (e.g. Tom), regulatory related organization (e.g. Jack Wong, founder of ARPA), NGOs, certification bodies (e.g. BSI, SGS) and government.

26 Standard Guideline on Good Regulatory Practice Proposed project timeline: Aug 2013: Organize teleconference for potential project team members to discuss and confirm objectives of GRPTF Sep-Oct 2013: Draft the guidelines of Good Regulation Practice. Nov 2013: Discuss and revise WHO Draft Guidelines on Good Regulation Practice by project team. Dec 2013: Draft guideline release and identify pilot audit 2014: Collect experience and feedback and do revision to GRP Guideline

27 Award

28 Award Student and RA operations Student Hosted by ARPA RA Alumni group RA Operations Gathering judge panel e.g. Clinica, Korn Ferry

29 5 core-activities (Kick off)

30 5 core-activities (Ideas)

31 5 core-activities (Achievements)

32 Learning Targets Industry, regulators AND students Speakers Combination of experts from different angle Cost Highest consideration factor

33 Jack Wong Director, Regulatory Affairs, Asia Pacific, TerumoBCT Mobile: Profession Summary: Over 19 years of Regulatory, Clinical Trial and Pharmacovigilence experience in Asia with good knowledge in the field of Medical Devices, Pharmaceuticals, Nutritional, Consumer Healthcare and Biological products Externally, playing a leading role among all the Regional Regulatory professionals in AHWP (Asian Harmonization Working Party), and was invited to provide regulatory training to local universities and industry organizations. Prof Wong also very active in ASEAN, APEC, ISO and WHO projects In his professional career, Prof Wong developed the First Asia Regulatory Affairs Certificate since 2007 with more than 1400 students in alumni. He is also founder of ARPA (Asia Regulatory Professional Associations) since 2010 with more than 1200 members and Asia GRP (Good Regulatory Practice) Research Centre since 2011 with more than 10 companies supporting. The First Asia Regulatory Book was launched in May