Newsletter – HK and Asia Regulatory · AHWP Hong Kong representative Email: [email protected] 3. Macau Regulatory HKMRS (Hong Kong and Macao Regulatory Service Limited) is

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

Convener Contact Jack Wong AHWP Hong Kong representative


AHWP Annual meeting update

(Please reserve 4-7 Nov 09)

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

Mr Gunter Frey Senior Auditor, Philips Healthcare SG3 Update

Ms. Jan Welch Food and Drug Administration, Center for Devices and Radiological Health, USA (Chair of GHTF SG4) SG4 Update

Mr Greg LeBlanc Manager, Regulatory Affairs and Quality Systems, Cook ( Canada) Inc., Canada (Vice-Chair of SG5) SG5 Update

Mr Jeffrey Gren APEC Project Overseer and Director, Office of Health and Consumer Goods, U.S. Department of Commerce AHWP-APEC Collaboration



Regulatory Forum in Singapore

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.



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.



Summary of Procedures • Site Master File (clause 2.2.2)

– Introduction to GDPMDS – Quality Management system – Resource management – Storage and stock handling – Traceability – Product Complaint – Field Safety Corrective Action – Returns – Disposal – Counterfeit Devices – Internal Audits – Management Review – Outsourced Activities Please also note there are 12 product categories for GDPMDS application: 1. Active implantable devices 2. Anesthetic and respiratory devices 3. Dental devices 4. Electro mechanical medical devices 5. Hospital Hardware 6. In vitro diagnostic Devices 7. Non-active implantable devices 8. Ophthalmic and optical devices 9. Reusable instruments 10. Single-use devices 11. Technical aids for disabled persons 12. Diagnostic and therapeutic radiation devices

For further clarification or assistance required for GDPMDS, you may like to contact

Carol Sim, at [email protected] or +65 9749 2832.



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



* Fee for product listing

* Class I listing

* Product renewal

* Change of Particulars

* "Accessories" in product listing certificate

* Grace period upon mandatory MDACS

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



2. HKAPI update

Sabrina Chan (from Hong Kong Association of Pharmaceutical Industry) provided updates on pharmaceutical regulatory issues

Potential new requirement of microbial testing in Hospital Authority

1. Proof of compliance to microbiological test requirements

a. Sterile Product: Proof of sterility through evidence shown on product

b. Non-sterile Product: Proof of compliance to microbiological test requirements

of BP, USP, or EP

2. More routine sample testing:

a. Testing method: ID and Assay, microbiological testing

b. Frequency: increased and routine with schedule

3. Supply of batch release reports

4. Additional Information on delivery note

a. Registration particulars: eg. registration numbers, expiry date…

5. Multi-sourcing

6. A valid Check and Chase system – supply chain logistics

Product Classification service

Please note Hong Kong Department of Health has stopped classification service for pharmaceuticals.

* Message from BSI

Please contact BSI if you need Classification service from third parties



3. Macau Regulatory

HKMRS (Hong Kong and Macao Regulatory Service Limited) is a HK consultancy company providing regulatory services to clients in HK and Macao.

In additional to regulatory services for pharmaceutical products and



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]



4. Working with the Media

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.



5. Hong Kong Regulatory update

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

www.monsoncommunications.com | [email protected] | cell : 415.297.8100

�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.

(continued on pg. 2)

Communi ca t ing E�e c t i v e l y :

An IPO In Your Future?by Me l i s s a Mon son

copyright © Melissa Monson, 2009

Melissa Monson, one of our previous speakers, is sharing tips with a regular column “Communicating E�ectively.” Hope you �nd it helpful. - Jack Wong

www.monsoncommunications.com | [email protected] | cell: 415.297.8100

(continued from pg. 1)

Drafting the Roadshow

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

capitalizing your message in global markets.

copyright © Melissa Monson, 2009

China Regulatory Forum

(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

Training registration or query

[email protected]

[email protected]

* 2 SZ FDA staff confirmed attendance of the above Certificate course on 16-17

Sept

全球医疗器械法规证书课程全球医疗器械法规证书课程全球医疗器械法规证书课程全球医疗器械法规证书课程

亚洲地区首个医疗器械法规资质证书课程亚洲地区首个医疗器械法规资质证书课程亚洲地区首个医疗器械法规资质证书课程亚洲地区首个医疗器械法规资质证书课程

一把打开全球各个国家医疗器械市场的金钥匙一把打开全球各个国家医疗器械市场的金钥匙一把打开全球各个国家医疗器械市场的金钥匙一把打开全球各个国家医疗器械市场的金钥匙

时间时间时间时间: 2009年9月16-17日

地点地点地点地点: 深圳市北环大道7001号开元大厦(景田北), 实华酒店

课程背景课程背景课程背景课程背景：：：：

符合法规的要求对于医疗器械行业是商业成功的核心关键。注册的拖延和更新的拖延

会对业务产生重大的影响，各个国家的法规又处于持续的变化之中，而亚洲地区至今未有任何

机构可以提供全面的法规培训及颁发正式的法规培训资质证书。

BSI和全球各个国家的法规制定机构、法规执行机构及法规专家合作，很荣幸地在中国

设立了首个法规资质证书课程。该证书课程专为法规人员，商务人员和质量人员量身定制。

医疗器械是全球化产业，该培训课程将不仅覆盖中国的法规还囊括全球主要国家法规

内容。除获取知识外，BSI还将搭建一个平台，供法规人员定期交流以提供强有力的法规数据

库及信息分享网络。BSI还将和您分享大量的实践案例，从中帮助您学习一些关键的合规经

验，例如：如何管理法规项目，如何处理产品召回等。

主要议题主要议题主要议题主要议题

GHTF和AHWP简介

什么是医疗器械

医疗器械如何分类

ISO9001和ISO13485简介

美国和欧洲医疗器械法规

亚洲医疗器械法规和趋势（日本，韩国，印度，香港，台湾，新加坡，马来西亚，泰国，菲利

宾等）

费用费用费用费用

RMB 4,800元/人

语言语言语言语言

英语和普通话

证书证书证书证书

通过考试的学员将颁发法规培训证书

如需查询

[email protected]

[email protected]

* 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.


5. London Regulatory Conference’s special offer to Regulatory Forum participants

10% discount will be offered to Forum participants


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

Majed .A . Al-Qhtani Saudi FDA, Saudi Arabia

Felicia Chau Siemens Medcial Solutions Diagnostics Ltd

Grace Au SSL Healthcare

Kamswee Koo SSL Healthcare

Natalie Yan SSL Healthcare

Ronan Chan St Jude Medical

Cat Hui Yuen Ting St Jude Medical

Eddie Ngan The MacKay Group

Karen Lee Wyeth

Tammy Wong (Freelance Marketing Expert)

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

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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]