Newsletter – HK and Asia Regulatory Aug, 09 Number 8 In This Issue Regulatory Forum’s roles and successes AHWP update Singapore Forum Hong Kong Regulatory Forum Communication skill sharing China Regulatory Forum Regulatory Training Special Offers to Forum participants Convener Contact Jack Wong AHWP Hong Kong representative Email: [email protected]The Regulatory Forum’s roles and successes The Regulatory Forum, is a regular meeting opens to all companies or individuals, with the following terms of reference: - To hold regular meetings where medical device experts from different regions in Asia can share: good regulatory practice in relation to medical devices (and pharmaceuticals); discuss harmonization; and inform participants of regional regulatory developments; and - To provide updates on AHWP matters from both industry and government AHWP representatives via the Regulatory Forum newsletter, which is distributed to more than 5,000 readers globally. Its content is published in a number of leading industry magazines, including Clinica World Medical Technology News, The Regulatory Affairs Journal, The Journal of Medical Device Regulation, The China Medical Journal, Clinivation and The Medical Device Manual. Previous Forum newsletters can be downloaded from the following link: www.bsiamerica.com/HongKongRegForum Meetings The Regulatory Forum holds a number of meetings throughout Asia each year. The participation of forum is free of charge. 2008 Forum Schedule 18 Jan HK, 28 Mar HK, 4 Sept Taiwan, 1 Oct Vietnam, 7 Oct Thailand, 16-17 Oct London, 28 Nov HK, 3 Dec China (SZ) 2009 Forum Schedule 22 Jan HK, 20 Feb Thailand, 24 Apr HK, 29 Apr India, 18 May Saudi Arabia, 28-29 May Singapore, 10 Jul China (Beijing), 24 Jul HK, 17 or 18 Sept China (SZ), 21 Oct UK, 27 Nov HK, 2 Dec UK * Please contact Jack Wong if you would like to participate in any of these forums
31
Embed
Newsletter – HK and Asia Regulatory · AHWP Hong Kong representative Email: [email protected] 3. Macau Regulatory HKMRS (Hong Kong and Macao Regulatory Service Limited) is
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
The Regulatory Forum, is a regular meeting opens to all companies or individuals, with the following terms of reference: - To hold regular meetings where medical device experts from different regions in Asia can share: good regulatory practice in relation to medical devices (and pharmaceuticals); discuss harmonization; and inform participants of regional regulatory developments; and - To provide updates on AHWP matters from both industry and government AHWP representatives via the Regulatory Forum newsletter, which is distributed to more than 5,000 readers globally. Its content is published in a number of leading industry magazines, including Clinica World Medical Technology News, The Regulatory Affairs Journal, The Journal of Medical Device Regulation, The China Medical Journal, Clinivation and The Medical Device Manual.
Previous Forum newsletters can be downloaded from the following link: www.bsiamerica.com/HongKongRegForum Meetings The Regulatory Forum holds a number of meetings throughout Asia each year. The participation of forum is free of charge. 2008 Forum Schedule 18 Jan HK, 28 Mar HK, 4 Sept Taiwan, 1 Oct Vietnam, 7 Oct Thailand, 16-17 Oct London, 28 Nov HK, 3 Dec China (SZ) 2009 Forum Schedule 22 Jan HK, 20 Feb Thailand, 24 Apr HK, 29 Apr India, 18 May Saudi Arabia, 28-29 May Singapore, 10 Jul China (Beijing), 24 Jul HK, 17 or 18 Sept China (SZ), 21 Oct UK, 27 Nov HK, 2 Dec UK * Please contact Jack Wong if you would like to participate in any of these forums
Convener Contact Jack Wong AHWP Hong Kong representative
The Forum serves as the platform for AHWP representatives to update Asian regulatory issues. AHWP is the key regional regulatory group among regulators and industries to harmonize and share good regulatory practices in Asia Our coming annual AHWP meeting will be held on 4-7 November in Hong Kong with the following tentative schedule: Dates: 4-7 November 2009 4 November – AHWP TC meeting 5 November – AHWP Workshop 6-7 November – AHWP meeting Venue: Hong Kong Convention Centre Registration details will be announced in Jun 09 in AHWP website (www.ahwp.info) – please note the website address was changed The meeting will coincide with the HKTDC [Hong Kong Trade Development Council] Hong Kong International Medical Devices and Supplies Fair, which is scheduled for 4-6 November 2009.
Speakers confirmed
Dr. Ginette Michaud Center for Devices and Radiological Health, Food and Drug Administration, USA (Chair of GHTF SG1) SG1 Update
Ms Isabelle Demade Principal Administrator, European Commission (Chair of GHTF SG2) SG2 Update
A Regulatory training on GDP and forum was conducted in Singapore on 28-29 May 2009
GDPMDS (Good Distribution Practices for Medical Devices) aims to ensure product quality is maintained during storage and distribution. It acts as a standard to meet the above requirement and applies to storage practices such as Pest control, adequate storage areas, appropriate storage conditions, good storage practices (eg, EEFO – Earliest Expiry First Out) and proper documentation and records. BSI Singapore is amongst one of the Certification Body that has been awarded by Singapore Accredited Council (SAC) to provide certification for Good Distribution Practices for Medical Devices (GDPMDS). BSI Singapore office had successfully conducted “GDPMDS Sharing Seminar” with many companies that are interested in the application for certification to join and share their feedback and experience. Any company that has activities of importing or does wholesale of medical devices and wishes to apply for the Import or Wholesale license is required by law (under the Health Products Act – in 2007) needs to be certified to GDPMDS standard.
Convener Contact Jack Wong AHWP Hong Kong representative
The intent of standard is to ensure quality of medical devices is maintained throughout distribution chain. Stakeholders involved include: Your company (and any outsourced activities, eg 3rd party logistic), Health Science Authorities, Singapore Accreditation Council (SAC), and Certification bodies (e.g. BSI) GDPMDS auditable standard is known as: � TS-01 Good Distribution Practice of Medical Devices Requirements (Rev 1)
� Simplicity of the documentations – depend greatly on:
- Size and structure of organisation - Processes - Type of medical devices
� Have to justify any exclusion clause of TS-01 in the Site Master File.
What is Site Master File? Site Master File is a summary of requirements by the standard that includes information such as: scope of activities implemented, summary of procedures, and information about the premises.
Convener Contact Jack Wong AHWP Hong Kong representative
Hong Kong Regulatory Forum Update 1. The LRP Panel update (Free LRP membership) A priority discussion of the forum was Hong Kong’s new Local Responsible Person (LRP) regulation. The Regulatory Forum’s dedicated LRP Panel (established in June 2008 to facilitate communication among LRPs, CABs and the Medcial Device Control Office and to share LRP best practice) discussed this issue with attendees. Details about the new LRP requirements can be found at the following link: http://www.mdco.gov.hk/english/mdacs/mdacs_gn/files/cop_01_1sep2005.pdf
We were also very honoured to have Mr Camon Sin of Medtronic (Hong Kong) as Chairman. Ms Carman Lai (Hospira) was appointed as Vice-Chair. Ms Tammy Wong was appointed as Secretary, Ms Monita Lau was appointed as Legal Advisor, Jack Wong was appointed as Convener
Mr Camon Sin (Chair of HK LRP Panel) The several key discussions in the last LRP Panel meeting on 19th June 2009 were presented:
1) Role of LRP Panel
2) Appointment of Ms. Tammy Wong as the Panel Secretary
3) Key industry issues -
* indemnification clause in the GN-1 & COP-01
* SME compliance capacity
* LRP QMS
Convener Contact Jack Wong AHWP Hong Kong representative
The Panel decided to identify the key priorities to focus on in the coming year. This will be discussed in the next meeting tentatively on 29th September 2009 based on the principle of Panel meeting on a quarterly basis. After the urge for more industry members to join the Panel, a number of applications were collected at the end of the Forum and several queries were received from industry members who are interested in serving as Vice-chairs of the Panel.
Next LRP meeting
Date: Oct 8, 2009 (Thurs)
Time: 10:30 am to 1pm
Venue: Conference Room of Medtronic Hong Kong, 16/F Manulife Plaza, 33 Hysan Road, Causeway Bay
Guest of honor: Mr. Mark Lau, MDCO
LRP membership form and Regulatory Forum registration will be jointed together and emailed to participants
Convener Contact Jack Wong AHWP Hong Kong representative
medical devices, HKMRS also provide other services including Intellectual Property Rights protection and registration.
Regulatory Forum invited Mr. Luciano Baptista to share his experience on IP protection in conjunction with regulatory registration. There is a possibility even though registration with local health authority had been completed, the license holder may not be able to sell his products because of possible trademarks or patents restrictions. Mr. Baptista also mentioned 3 points of interest:
1. As IP protections are territorial, registration has to be done in different countries in order to secure the clients' interest.
2. Registration of trademarks has a duration, renewal is required in order to have continuous protection.
3. There are also different requirements in different countries, research maybe needed to ensure registration process to be smooth and expediously.
Mr. Baptista could be reach via the following address: [email protected]
Convener Contact Jack Wong AHWP Hong Kong representative
Veronica Sze (APCO Worldwide) was invited to share their experience on “ Working with the Media”
Understanding the current media eco-system and trends is essential to furthering your company’s reputation. The internet, including social media, has replaced print as the driver of media deadlines, agendas and content. As a result, competition among all other media categories has intensified, and media outlets and reporters from all types of media have been forced to further define their scope, depth and agenda.
As the structure of media has changed, so has the nature of reporters and the way they relate to corporations. Expect for your stories, good and bad, to be covered by the media. How you interact with reporters and respond to their inquiries will determine the tone, length and duration of the coverage.
“No comment” is no longer an acceptable response and timely, direct responses are expected. Personalize your messages to the type of media and reporter and communicate proactively when appropriate. Long-term relationships with reporters are critical to building your reputation with your key audiences.
Convener Contact Jack Wong AHWP Hong Kong representative
Raymond Poon and Jennifer Mak from Medical Device Control Office (Department of Health) and Jack Wong (BSI) provided the following updates
- AMDN (Asia Medical Device Nomenclature) was developed in HK and will be used to replace GMDN or UMDN for registration in HK. There is a plan to promote the use of AMDN in Asia through AHWP
- New application form for medical device listing was announced and company are recommended to use the new form
- For major product changes, companies are required to inform MDCO about the changes. BSI would suggest companies to inform MDCO on all the changes on the documentation submitted to MDCO before
- MDCO is working on the proposal on how to do Class I listing and LRP Quality System requirement and plan to roll out around end 09 for comment
�e Initial Public O�ering (IPO)* market while still in the doldrums in the US is doing quite well in China. Both private equity and venture backed �rms went public in the second quarter of this year and were listed on either the Hong Kong or New York Stock Exchange. Likewise in India where after a nine month slump companies and their investment bankers are lining up a series of IPOs to take advantage of increasing international interest to tap into the Indian market.
If there is a possible IPO in your company’s future, and you are waiting for the IPO market to turn around, take advantage of this time to learn about the process for taking your company public.
Start by assembling an experienced team of investment bankers, attorneys and accountants. �en you’ll write a prospectus; and �nally you’ll take your roadshow to brokers and institutional investors in designated cities around the world.
Preparation Is Critical
Going public entails making one of the most important series of presentations in your company’s history - one that involves selling your company to a wary public for the �rst time. You must ensure that your key people are prepared to give a well thought-out, clearly focused, enthusiastic presentation from start to �nish every time.
But most management teams are unprepared to tell and sell their company story. �ey are inexperienced at developing and delivering a succinct presenta-tion outlining the company’s investment potential complete with a winning presentation which must be delivered in 20 to 30 minutes.
Creating text and visuals for a roadshow begins with a drafting session and then the story is re�ned over the course of three to four weeks. �e �nal story must be compelling and easily understood.
Using E�ective Visuals
You must support your company story with a visually clean, simple, easy-to-understand and a professionally produced presentation that can explain a complicated technology or multi-product company.
Delivering the Presentation
- Can you synthesize and articulate the most important elements of your company’s investment story?
- Can you speak energetically and use eye contact?
- Are you comfortable in a stand up presentation?
- Does anyone on your team have an accent that could create communication problems?
- Do you have carefully crafted answers for that all-important Q&A session?
Go for it!
With coaching your team should deliver a relaxed, informative, crisp and persuasive presentation that will motivate potential investors to invest with you.
And, remember, a sharp presentation can boost the o�ering price!
* A company’s �rst sale of stock to the public. Securities o�ered in an IPO are often but not always those of young small companies seeking outside equity capital and a public market for their stock.
ROADSHOW PRESENTATIONS. MARKETING. PUBLIC RELATIONS. Melissa Monson is based in San Francisco, California. She develops roadshows, and coaches management teams who are raising equity in the private and public markets. She writes the column “Communicating E�ectively” for the Hong Kong Regulatory Forum and was a guest speaker in November 2008.
Communi ca t ing E�e c t i v e l y : An IPO In Your Future? b y Me l i s s a Mon son
(18 Sept 2009 open for registration) Further to the success of China Regulatory Forum last year, we would like to arrange a regular communication platform among government and industry. Next China Forum detail is as follow: Date and time: 18 Sept 2009 2:30-5:00pm Venue: It will be in Shenzhen China (exact venue to be confirmed by SZ FDA) Tentative agenda: AHWP and Asia Regulatory update - by BSI (Secretariat of AHWP) HK Medical Device Regulatory update - by HK Medical Device Control Office SZ/China Medical Device Regulatory update - by SZ FDA Report of last China Forum can be found in the following link http://www.bsiamerica.com/upload/MS-Assessment+Certification/Subject-Areas+Sectors/Healthcare+Medical-Devices/Documents/HK_CAB/HKRF-Newsletter-Nov08.pdf Pictures of last China Forum
Registration and Query Email name, title, company name and email address to [email protected]
Regulatory Trainings
BSI is the leader in providing regulatory trainings. Please find below the courses for your information:
Hong Kong Medical Device and LRP Certificate Hong Kong Pharmaceutical Regulatory Certificate China and Global Regulatory Certificate * These are the first certification course in HK and China
Hong Kong Medical Device Regulatory and LRP Certificate
(next one is 2-3 Nov)
Hong Kong Department of Health (MDCO) shared experience on LRP requirements. MDCO may check their legal entities, distribution records, technical documentations, promotional materials compliant with the UMAO (Undesirable Medical Advertisement Ordinance), labeling compliance, special listing information, the process and implementation of all the required SOP submitted to MDCO. MDCO may also collect products from market to conduct inspections or testings. LRP training syllabus
A LRP training was developed based on a syllabus agreed by MDCO and CABs as follow:
MDACS and MDCO introduction Basic medical device regulatory - definition of medical device - medical device classification - tracking of specific medical devices - special listing information - Obligation of LRP - UMAO - Pharmaceutical product definition and regulatory requirement in HK Product knowledge on intended uses and contra-indication Preparation for application submissions Practical session - Distribution record SOP implementation - Complaint handling SOP implementation - Maintenance and services arrangements SOP implementation - Product alert, modifications and recall SOP implementation - Adverse event reporting SOP implementation - Prepare for MDCO audit Others - AHWP, GHTF introduction - Basic ISO 9000 and 13485 understanding
Base on the above syllabus, the 1
st LRP training was organized on 25-26 Nov 08 and we
have training every 3-4 months. The next one is 2-3 Nov 09 in Hong Kong A list of students who passed the exam was published in the newsletter (please refer to later part of the newsletter)
Pharmaceutical Regulatory Certificate
(next one is 14 Oct)
After discussion with the HK PDA (Hong Kong Pharmaceutical Distributors Association) and Department of Health (Pharmaceutical Section) a Regulatory certificate training was developed. The coming training is 3 Jun, Tina Yap (chair of HKPDA) and Anthony Chan (Chief Pharmacist of DOH) will attend and give opening speech
Details of the training course can be found below
Regulatory Certificate Program
Date: 3 June (10:30am-4pm) Why attend? Regulatory is critical to your business (Quicker and Quality registration approval means significant competitive advantage) and fatal to your business (Regulatory requirement is legal requirement, non-compliance means penalty and imprisonment) Topics to be covered:
10:30am - 12:30am Roles/Values of industry/Distributor (to be presented by HKPDA) What are pharmaceutical products What product needs to be registered and how to do classify them Whom to deal with and how to work with government What materials need to be submitted and why they are required How to review the material before submission 1:30pm - 3:30pm What to do if DOH raised questions How to manage regulatory projects How to do handle product recalls and re-labelling UMAO understanding 3:30pm - 4:00pm A 30mins examination will be arranged at the end * Certificates will be issued to participants who passed the exam
Next training Next one is on 14Oct. Please contact Jack Wong if more detail is required
China and Global Medical Device Regulatory Certificate
(Coming one is 16-17 Sept)
Date: Sep 16-17th, 2009
Venue: Number 7001. Beihuan Avenue.Futian District .Shenzhen
Why attend?
Regulatory function is vital to business. Late registration or late renewal could create
significant business impact. Regulatory regulation is also keep on changing. In the
past, there is no formal regulatory training certificate in Asia.
We work with different regulatory experts globally and proudly create the FIRST
Regulatory Affairs Certificate in China. This certificate program is designed for
regulatory, commercial and quality staff
Medical Device business is getting global and hence this training will not only cover
China regulatory but also key countries globally.
Not only acquiring knowledge, BSI would like to create a platform for regulatory
staff to gather regularly to build stronger regulatory network
BSI will also share some key regulatory processes experiences e.g. how to manage
regulatory projects, how to handle product recalls etc
Topics to be covered:
Introduction of GHTF and AHWP
What is medical device
How to classify medical device
Basic 9000 and 13485 introduction
US and Europe medical device regulatory
Asia medical device regulatory and trend (Japan, Korea, India, Hong Kong,
Taiwan, Singapore, Malaysia, Thailand, Philippines etc)
Fee
RMB 4,800 per person
Language
English and Mandarin
Certification
Certificate will be issued to participants who passed the exam
* 2 SZ FDA staff confirmed attendance of the above Certificate course on 16-17
Sept
* Email Jack ([email protected]) if you do not want to receive this newsletter
Others and Special Offers to Forum participants
1. JMDR special offer to Regulatory Forum participants
Journal of Medical Device Regulation offers special pricing to forum participants. Please use the code “HK0808” code when making an order
Details can be found at the later part of newsletter
2. Special offer to Regulatory Forum participants from Medical Device Manual
The Medical Devices Manual is a practical, comprehensive guide for all those working with medical devices. Euromed Communication is offering a Special Offer £200 (original price £290) for Regulatory Forum participants. An order form can be found at the later part of newsletter
3. Clinivation WorldView special offer to Regulatory Forum participants
Clinivation WorldView is the medical device and diagnostic industry's most comprehensive, authoritative, and up-to-date enterprise solution for On-Demand Global Regulatory Intelligence. Providing clear, step-by-step market clearance regulations, processes, and guidance for >99% of the world markets, only Clinivation WorldView delivers tried-and-true intelligence from certified, practicing professionals with real-world experience
BSI is also a subscriber of Clinivation WorldView and partner for Asia promotion. Please contact Jack Wong ([email protected]) for special Forum pricing. Detail of the WorldView can be found at the later part of newsletter
4. Hong Kong Medical Fair’s special offer to Regulatory Forum participants
All new exhibitors can enjoy a 5% first-time exhibitor discount while overseas exhibitors (excl. Taiwan, mainland China and Macau) can enjoy 3-night accommodation (1 room) at a designated hotel.
Details can be found at the later part of newsletter
5. London Regulatory Conference’s special offer to Regulatory Forum participants
10% discount will be offered to Forum participants
Details can be found at the later part of newsletter
Students completed the Medical Device Regulatory training
Name Organization Ricky Ho Alcon
Susan Leung Asia Cardiovascular Products Ltd
William Ku Asia Cardiovascular Products Ltd
Deborah Kwong BD
Carol Chen BD
Ivy Kwok BD
Petty Fan BD
Gloria Poon Baker & McKenzie
Mr. Cheney Lu Baker & McKenzie
Flora Lee Bayer HealthCare Ltd
Jo Choi Bayer HealthCare Ltd
Manson Chung Bayer HealthCare Ltd
Catherine Cheng Bayer HealthCare Ltd
Maggie Leung Boston Scientific
Christine Tsai Boston Scientific
James Fan Boston Scientific
Mandy Yau Baxter Healthcare Ltd
Cecilia Chan British Consulate General
Leung, Man Cho Chinese University of HK, School of Pharmacy
Fong, Yui Kau Chinese University of HK, School of Pharmacy
Mok, Siu Man Shirley Chinese University of HK, School of Pharmacy
Chan, Ka Yan Chinese University of HK, School of Pharmacy
Chan, Yat Hei Chinese University of HK, School of Pharmacy
Leung, Man Cho Chinese University of HK, School of Pharmacy
Winki Ip Chinese University of HK, School of Pharmacy
Audrey Shum Clifford Chance
Dr Francis Kua Constraint Management Center
Mr K K Chow Constraint Management Center
Fatima Lai Consulate General of Canada
Olivia Chan Dentsply
Vissica Wong Dentsply
Martha Lee DKSH
Lawrence Yiu DKSH
Kayley Wong Ferring Pharmaceuticals
Sabrina Chan HKAPI (HK Association of Pharmaceutical Industry)
Jenny Wan HKAPI (HK Association of Pharmaceutical Industry)
Mr CHIU Chi-Sang (LUCIANO BAPTISTA) HKMRS (Hong Kong and Macau Regulatory Service) Ltd
K C Lee Hong Kong Standards and Testing Centre Limited
Carmen Lai Hospira Ltd
Pandora Cheung InvestHK
Maggie Ho Janssen Pharmaceutical
Jenny Ho Johnson & Johnson Medical
Frederic Campana LNE Shanghai
Doris Cheng Medtronic
Janice Wei Medtronic
Emily Chiang Medtronic
Jessie Wong Medtronic
Erica Poon Merck Pharmaceutical
Sun Qin Molnlycke Healthcare
Monita Lau Or & Lau, Solicitors
Edgar Leung Orbit Medical Device Company Ltd
Iva Ng OrbusNeich Medical Co Ltd
Carin Ribbesjö-Lundqvist Q-Med
Fanny Wong Q-Med
Ulf Lundqvist Q-Med
Ronald Lo Roche Diagnostics (HK) Ltd
Abdulielah. K . Al-Mutairi Saudi FDA, Saudi Arabia
KHALIL .H . AL GHAMDI Saudi FDA, Saudi Arabia
AMJAD . S .ALGHAMDI Saudi FDA, Saudi Arabia
Faisal . A . Alshehri Saudi FDA, Saudi Arabia
Ziad. F. Alsabelah Saudi FDA, Saudi Arabia
ALI . M .ALHAWAS Saudi FDA, Saudi Arabia
Sultan . A . ALkanhal Saudi FDA, Saudi Arabia
HUSSAM . M . ALAEQ Saudi FDA, Saudi Arabia
Fahad . H . Al-Mujalli Saudi FDA, Saudi Arabia
Abdulrahman . A .Al-Swayed Saudi FDA, Saudi Arabia
Next Medical Device Regulatory training in 2009 is as follow: 2-3 Nov 09 Contact Jack Wong (BSI) for detail of the training: [email protected]
Students completed the Pharmaceutical Regulatory training
Name Organization Vam Cheng Allergan
Geoffrey Kok Allergan
Rose Mak American Consulate General
Yolanda Yan Amgen
Susie Chan AMO Asia Ltd
Susanna Leung Asia Cardiovascular Products Ltd
Yemmie Tsang AstraZeneca
Stanley Yu AstraZeneca
Susanna Yim Bausch & Lomb (HK) Ltd
Mr Cheney Lu Baker & McKenzie
Stephanie Poon Baker & McKenzie
Gloria Poon Baker & McKenzie
Jingyan Wei Baker & McKenzie
Catherine Cheng Bayer HealthCare Ltd
Flora Lee Bayer HealthCare Ltd
Vivien Lee B Braun Medical
Cecilia Chan British Consulate General
Winki Ip Chinese University of HK, School of Pharmacy
Timothy Chan Chinese University of HK, School of Pharmacy
Leung Man Cho Chinese University of HK, School of Pharmacy
Fong Yui Kau Chinese University of HK, School of Pharmacy
Mok Siu Man Chinese University of HK, School of Pharmacy
Chan Ka Yan Chinese University of HK, School of Pharmacy
Chan Yat Hei Chinese University of HK, School of Pharmacy
Sidney Ng CK Life Sciences Int'l., Inc.
Keith Kei CK Life Sciences Int'l., Inc.
Audrey Shum Clifford Chance
Fatima Lai Consulate General of Canada
Winnie Chung Consulate General of Canada
Dr Francis Kua Constraint Management Center
Mr K K Chow Constraint Management Center
Michael Li CSL Biotherapies Asia Pacific Ltd
Dominic Chan Daiichi Sankyo Hong Kong Limited
Ho Ping Him Daiichi Sankyo Hong Kong Limited
Lawrence Yiu DKSH
Louisa Ip Dorsey & Whitney
Katherine Lai Ferring
Agnes Sin Fresenius Kabi Asia Pacific Ltd
Wendy Cheng Gakderna Hong Kong Ltd
Pang Chuen Yee Hing Wing Co Ltd
Wilson Lun Hing Wing Co Ltd
Sabrina Chan HKAPI (HK Association of Pharmaceutical Industry)
Jenny Wan HKAPI (HK Association of Pharmaceutical Industry)
Mr CHIU Chi-Sang (LUCIANO BAPTISTA) HKMRS (Hong Kong and Macau Regulatory Service) Ltd
Pandora Cheung InvestHK
Maggie Ho Janssen Pharmaceutical
Florence Law Janssen Pharmaceutical
Jenny Ho Johnson & Johnson Medical
Kanes Hau Johnson & Johnson Medical
Janet Lai Mei Ho Lundbeck Hong Kong
Chris Kai Cheong Chow Lundbeck Hong Kong
Edgar Shiu Lam Liu Lundbeck Hong Kong
Vincent Wong Ka-Chun Mannings
Michael Chan Mannings
Doris Cheng Medtronic
Comte Chan Mentholatum Asia Pacific Ltd
Vincent Tsui Mentholatum Asia Pacific Ltd
Emily Lee Merck Sharp & Dohme
Erica Poon Merck Pharmaceutical
Kane Leung Novo Nordisk Hong Kong Ltd
Daniel Cheung Novo Nordisk Hong Kong Ltd
Suk Chan Novo Nordisk Hong Kong Ltd
Monita Lau Or & Lau, Solicitors
Sophie Li OrbusNeich Medical (Shenzhen) Co., Ltd.
Corinna Li Reckitt Benckiser Hong Kong Ltd.
Jenny Leung Reckitt Benckiser Hong Kong Ltd.
Anthy Ng Reckitt Benckiser Hong Kong Ltd.
Britta Snackers Sandoz
Tony Ko Servier
Maria Kong Servier
Tess Yeung Servier
Sean Morley Starcon Corporation
Raymond Lee Stiefel Laboratories (HK) Ltd
Peggy Yau Synovate Healthcare
Jennifer Lee Synovate Healthcare
Jesscia Chan Takeda
Timothy Chan TCM Healthcare (London) Ltd
Quincy Leung UCB Pharma Ltd
Raccoon Chung Watsons
May Yip Watsons
Danny Chan Watsons
Derek Chow Chun-Pong Watsons
Accacia Ku Wyeth
Karen Lee Wyeth
Vincci Yip Wyeth
Calvin Chan Wyeth
Tammy Wong (Freelance Marketing Expert)
Sung Kai-Yi (Personal)
Eddie Ngan Chiu-Kwong (Personal)
Next Pharmaceutical Regulatory Training in 2009 is as follow: 14 Oct, 11 Dec 20 09 Contact Jack Wong (BSI) for detail of the training: [email protected]
FAX TO: +44 (0) 1305 770836
** SPECIAL OFFER to HK Medical Device Regulatory Forum Participants **
3 BOOKS FOR THE PRICE OF 2
Choose any 3 publications from the list below and get the one with the lowest price for FREE
1. I would like to order (please tick as appropriate):
� Medical Device Regulations in the Americas March 2009 - £165
� The US FDA PMA Filing and Approval Experience November 2008 - £49.99
� Guidance on the Essential Requirements of the European Medical Devices Directive (MDD) August 2008 - £175
� Medical Device Regulatory Requirements in China and Hong Kong June 2008 - £49.99
� Medical Device Regulations in Europe (Countries N to Z) April 2008 - £165
� Medical Device Regulatory Requirements in Iran February 2008 - £49.99
� Medical Device Regulations in Europe (Countries A to M) November 2007 - £165
� Reimbursement of Medical Devices in France, Germany, Italy, Spain & the UK October 2007 - £64.99
� Key Revisions to the European Medical Device Directive, 93/42/EEC August 2007 - £129.99
� Medical Device Regulations in Asia, Africa and the Middle East April 2007 - £165
� A Beginners' Guide to the European Medical Devices Directive (MDD) February 2007 - £49.99
� A Summary of WEEE Legislation and Compliance in the EU Member States November 2006 - £49.99
2. Your contact details (please use BLOCK CAPITALS):
Your name: Mr/Ms/Dr _____________________________________________________________________________
VAT number: ___________________________________________________________________ All companies located in the European Union will be charged 15% VAT on the rates quoted above unless a valid VAT registration number is provided (VAT exemption does not apply to UK companies). Companies located outside the European Union will not be charged VAT.
4. Payment options:
� I enclose a cheque for ____________ made payable to ‘Global Regulatory Press’
All publications are supplied as a PDF by email and all orders are subject to Global Regulatory Press standard Terms & Conditions of Use.
21-22 October 2009, Danubius Hotel Regents Park, London
10% discount* for Regulatory Forum Participants
QUOTE CQ7066BD1Offer available until 18 September 2009
*off top price tier only
Prepare for your New Legal Responsibilities
in HK and Asia?
BSI, your regulatory partner in medical device and pharmaceuticals
Around 2010, many Asian countries including Hong Kong, Malaysia, Singapore and India etc will have implemented their brand new Medical Device Regulations BSI (British Standard Institution英國標準協會) could be your best regulatory partner to help you:
� understand the new regulations, � get product and manufacturer certifications quicker, � ensure your SOPs (especially recall SOP) ready, � survive LRP inspection by MDCO, and � more tailor made regulatory services The link for you to understand the HK regulatory system and download Asia newsletters is: www.bsiamerica.com/HongKongRegForum For more information, please contact Jack Wong Vice President Regulatory Affairs, Asia; General Manager, Hong Kong, BSI Email: [email protected]