Our 2017 Symposium has been reported in the latest issue of MIMS Oncology Hong Kong. The two-page coverage is attached can be found in the link below, under page 12 to 13. Happy Reading!
Saturday, April 1, 2017, 8:00 – 16:15
2017年4月1日 – 星期六 8:00- 16:15
18 Hanoi Road, Tsim Sha Tsui, Kowloon
Hong Kong, China
香港九龍尖沙咀河內道 18 號
電話： + 852 2311 1234
Cancer Research Symposium is committed to offering a program of high-quality, innovative research that is focused on the entire range of preclinical, translational, and clinical cancer therapeutics. Specific areas of interest include preclinical and translational research in development of novel small molecules and targeted therapies; biomarkers of response and/or resistance; novel experimental model systems and technologies relating to cancer screening and therapeutics; pharmacogenetics and pharmacogenomics; personalized or precision medicine; immunotherapy and clinical immunology. While research professionals will be kept abreast of the latest international guidelines for good clinical practice.
- Discuss what is new on the horizon in the battle against cancer.
- Differentiate between cancer trials and other therapeutics in the conduct of clinical research.
- Discuss the principles of pharmacokinetics and pharmacodynamics in cancer drug development.
- Formulate bio-availability and bio-equivalence (BABE) evaluations for multi-sourced drug applications.
- Define the operational and clinical impact of the recent addendum ICH GCP E6 R2 to the research professionals.
PROGRAM at A GLANCE
8:00 – 8:45 Registration & Breakfast. Sponsors Setup.
8:45 – 9:00 Welcome Remarks & Introduction to AM Session – Dr. C K Kwan, Symposium Co-Chair
9:00 – 9:30 Phase 1 Clinical Oncology Trials – Chia-Chi (Josh) Lin, MD, PhD
9:30 – 10:00 Precision Medicine for Cancer Treatment – Qin-yong Dai, MD, PhD
10:00-10:30 Immunotherapy and Cancer – Dr. Aung Myo
10:30-11:00 Coffee Break
11:00-11:30 Epidemiological Studies in Oncology – Professor Tai Hing Lam
11:30-12:00 Breakthrough Technology in Cancer Screening – Professor Dennis Lo
12 to 1 pm Lunch
13:00-13:15 Introduction to PM Session – Dr. C S Chang, Symposium Co-Chair
13:15-13:55 RECIST and irRECIST in Cancer Therapy – Oliver Bohnsack, MD, PhD, MBA
13:55-14:40 Pursuit of Excellence in Oncology Research-Progress in Therapeutics for Nasopharyngeal Carcinoma (NPC) – Professor Anne Wing-Mui Lee
14:40-15:00 Coffee Break
15:00-15:30 The Importance of Pharmacokinetics (PK) Studies, Bioavailability and Bioequivalence (BABE) Evaluations in Oncology Research – Professor Brian Tomlinson
15:30-16:00 Recent Changes in ICH GCP E6 R2 Impacting Sponsors, CROs, Clinical Investigators and Sites – Dr. Benny Fok
16:00-16:10 Closing Remarks – Dr. C S Chang, Symposium Co-Chair
16:10 Distribution of Certificates to Attendees
Oncology Research Symposium Co-Chairs:
Dr. Chung-Kong KWAN, FRCR, FHKCR, FHKAM, CPI, MPM (關仲江醫生)
Consultant in charge, Department of Oncology, United Christian Hospital. Visiting Consultant, Department of Clinical Oncology, Queen Elizabeth Hospital
Dr. Cheng-Shyong CHANG, MD, CPI (張正雄醫師)
Attending Physician, Division of Hemato-Oncology, Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taiwan. Assistant Professor, National Formosa University, Yunlin, Taiwan
CONTINUING EDUCATION CREDITS
Five (5) Continuing Medical Education / CPD Points (three for pathologists) have been approved by the Hong Kong Academy of Medicine (HKAM Reference Code: AM54401).
This symposium has been granted CME accreditation by the Hong Kong College of Physicians (HKCP). In accordance with the guidelines laid down by the Medical Council of Hong Kong on CME Program for non-specialists, accredited activities are open to all doctors. HKAM Reference Code: AM54401, Passive CME Points: 5.
ACRP certificants can self-report this activity to ACRP for certification maintenance purposes.
- Log onto the ACRP website (www.acrpnet.org<http://www.acrpnet.org>) with their credentials – their User ID is their email address. Forget password? Please contact Giovanna Lancaster directly to reset the password.
- Click on My Account on the right hand side.
- Click on Contact Hour History.
- Click Add and a pop-up window will appear – Enter the information.
- Click Save.
Giovanna Lancaster, Certification Specialist
[In alphabetical order]
Oliver Bohnsack, MD, PhD, MBA, is Senior Director Scientific and Medical Services with PAREXEL Medical Imaging and Patient Technology Solutions. He is Head of Oncology based in Berlin, Germany. Dr. Bohnsack received his Masters in Business Administration in Health Care Management from the University of California, Irvine and his PhD in radiology, radiation modulation and reduction, from the University of Munich. He is a board certified radiologist in Germany and USA. Throughout his 13-year career with PAREXEL, he has medically and scientifically led and managed the imaging components of more than 300 clinical trials. He has developed equally as many imaging charters for various indications and complexities and has contributed to the approval of 14 oncology compounds. Dr. Bohnsack regularly presents at international conferences and publishes on Imaging in Clinical Trials, especially regarding the use of standardized review criteria and imaging based endpoints. He is co-author of the immune-related response criteria (irRC, 2009) and first author of irRECIST (2014). Dr. Bohnsack will present the latest updates on the topic “RECIST and irRECIST in cancer therapy". The handbook “Adaptation of the Immune-Related Response Criteria: irRECIST" will be distributed at this lecture.
Dr. Qin-yong Dai, MD, PhD, Medical Director, Medical Department, Roche Hong Kong. Dr. Qinyong Dai graduated from the medical school at Shanghai Jiao Tong University. He received medical training and clinical practice in Shanghai Ruijin Hospital, followed by two years of specialty training in bone marrow transplantation in Lyon, France. He also holds a Ph.D in experimental medicine from McGill University, Canada. In 2006, he joined GSK Biological, Hong Kong. Currently, he is the medical director of Roche Hong Kong, leading medical affairs, clinical development and regulatory affairs. He has been working on clinical trials of different therapeutic areas for over ten years. Dr. Dai will present Precision Medicine for Cancer Treatment and discuss how the development of drugs that targets the complex molecular interactions which drive the progression of cancer.
Benny Fok, PhD, 霍兆邦先生, is currently the Quality and Regulatory Manager of the Clinical Research Management Office (CRMO) and the Scientific Officer of the Division of Clinical Pharmacology, Department of Medicine and Therapeutics, The Chinese University of Hong Kong (CUHK). He received his GCP and clinical research training in North America and GCP audit training in the United Kingdom. Mr. Fok is currently a Certified Clinical Research Coordinator and a certified GCP trainer of ACRP. Mr. Fok has managed over a hundred early phase clinical trials including over 80 bioequivalence studies. Mr. Fok is also responsible for the CFDA accreditation of the BABE unit at the Prince of Wales Hospital since 2006.
For the first time in 20 years, the International Conference for Harmonization (ICH) Good Clinical Practice (GCP) E6 Guideline has been significantly updated in June 2015. The revisions are intended to encourage implementation of more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial data. It is important for organizations running clinical trials to understand the changes, the reasons behind them, and how they will be affected. It is also equally important to understand how to go about implementing those changes in an effective and efficient manner. Mr. Fok will present his talk The Recent Changes in ICH GCP E6 R2 Impacting Sponsors, CROs, Clinical Investigators and Sites. He will give an overview of the changes with summary explanations of the changes, per the Guideline. Topics include: ICH principles, ICH definitions, sponsor/CRO responsibilities, investigator responsibilities, and essential documents.
Professor Tai Hing Lam, 林大慶教授, is Sir Robert Kotewall Professor in Public Health, Chair Professor and Director, School of Public Health, The University of Hong Kong. Professor T.H. Lam graduated from the Faculty of Medicine, The University of Hong Kong with the MBBS degree in 1975. He got an MSc degree in medical sociology and an MSc degree in occupational medicine from The University of London in 1980 and 81 respectively. He obtained his MD degree by research from The University of Hong Kong in 1988. He is Director of the School of Public Health since August 2009. Prof Lam has received many awards on recognition of his contribution in advocacy for tobacco-free societies, excellence in medical education, scientific research and health promotion locally and internationally. He will discuss Epidemiological Studies in Oncology.
Professor Anne Wing-Mui Lee, 李詠梅教授, Clinical Professor and Head, Department of Clinical Oncology, The University of Hong Kong (HKU), Honorary Consultant at Queen Mary Hospital, Chief of Service at HKU-Shenzhen Hospital, Chair of Oncology at Gleneagles HK Hospital, and many other positions. Currently Prof. Lee is the Vice President of Hong Kong College of Radiologists and the Vice Chairman of Hong Kong Anti-Cancer Society. She also serves in many international academic organizations, including being the Coordinator of the Global Advisory Group and a member of TNM Expert Advisory Panel on Head and Neck Cancers for the Union for International Cancer Control; Vice-Chairman of the National Cancer Staging Committee of China. Prof. Lee serves in editorial board of many international journals, including as an Associate Editor for Oral Oncology, a member of the Board of Editors for Journal of Clinical Oncology, Radiotherapy & Oncology, and Clinical Oncology. Prof. Lee has received many awards and honors including the Gilbert Fletcher Distinguished Professor Lecturer by MD Anderson Cancer Center. For more information, please visit: http://www.oncology.hku.hk/staff_alee.html
Chia-Chi (Josh) Lin, MD, PhD, 林家齊醫師. Dr. Lin is director of the Phase I Center, department of oncology at National Taiwan University Hospital, and clinical associate professor in the department of urology at the National Taiwan University College of Medicine. He received his MD, PhD, and specialty training in medical oncology at the National Taiwan University College of Medicine. He was formerly a clinical research fellow at the Institute for Drug Development, Cancer Therapy and Research Center in San Antonio, Texas, in 2006, and at Clinical Research Services at Scottsdale Healthcare, Translational Genomics Research Institute in Scottsdale, Arizona in 2007. Dr. Lin has authored more than 20 peer-reviewed manuscripts. His main research interests include early phase drug development, as well as novel therapies for thoracic (esophageal cancer, lung cancer) and genitourinary (transitional cell carcinoma, renal cell carcinoma, prostate cancer) malignancies. Because of his dedication to medical oncology and early phase drug development, the Taiwan Oncology Phase I Trial Consortium (TOPIC) appointed Dr. Lin executive secretary. He is an active member of the American Association for Cancer Research and the American Society of Clinical Oncology.
Professor Dennis Lo, 盧煜明教授, Associate Dean of Research at The Chinese University of Hong Kong (CUHK), will speak about breakthrough technology in cancer screening. Prof. Lo is listed on the MIT 2015 List of 10 Breakthrough Technologies: https://www.technologyreview.com/lists/technologies/2015/ Prof. Lo is one of the two winners of the Future Sciences Prize, the Chinese version of the Nobel Prize. He took home the Life Science Prize while Tsinghua University physicist Professor Xue Qikun bagged the Physical Science Prize for his discoveries in quantum phenomena. Each of them won US$1 million. Recently, at the Future Forum 2017 and inaugural ‘Future Science Prize’ Award Ceremony held in Beijing, Professor Dennis Yuk-ming Lo received the ‘Life Science Prize’ in front of Nobel Prize laureates, scores of top international scientists and entrepreneurs, and over a thousand guests from around the world. For further details, please visit: http://www.cpr.cuhk.edu.hk/emotion/2017/2/indexe.html#a1
Dr. Aung Myo is the Executive Director, Regional Medical Leader, Oncology-Medical Affairs, Asia Pacific-India-China at Merck Sharp & Dohme (MSD). His office is in Singapore. A medical oncologist, with a broad and deep range of experience in pharmaceutical industry for both clinical development and medical affairs in the oncology area, Dr. Myo leads a regional team of clinical and medical affairs for cancer immunotherapeutic, working with 9 countries across Asia Pacific. He is the regional leader for clinical development of oncology trials, ranging from tumor marker (Epi) studies to various phases of clinical trials and investigator-sponsored studies in Asia Pacific. Experienced in global clinical development as the leader for cancer indication, Dr. Aung Myo is involved in IND application, safety and compliance. Dr. Myo is the lead of “new product introduction” team (commercial, regulatory, market access teams) for launch preparation in the region and provides medical support and oversight to launch and post-launch activities. He also organizes regional advisory boards and medical educational activities, and has peer-to-peer relationship with oncology experts in the region. A good track record of scientific oncology publications and a speaker at Asia-Pacific conferences, Dr. Myo’s specialties include clinical development, cancer immunotherapy, medical monitor and advisor, among many others.
Professor Brian Tomlinson, MD, PhD, 湯寧信教授, will speak about pharmacokinetics, bioavailability and bioequivalence pertinent to cancer drugs. Professor Tomlinson was previously a Chair Professor of Medicine and Therapeutics in the Department of Medicine and Therapeutics at The Chinese University of Hong Kong, where he spent 25 years in academic appointments. He was also Honorary Consultant Physician at the Prince of Wales Hospital in Hong Kong and Clinical Toxicologist in the Poison Treatment Centre there and was Clinical Director of the Clinical Pharmacology Studies Unit, which performs clinical trials at all stages of drug development including Phase 1. For more about Prof. Tomlinson, please visit: http://www.p1ctc.med.cuhk.edu.hk/OUR-RESEARCHERS/BABE
Sorry, Registration is now full.
We limit our symposium class sizes so that they are not overcrowded. Please email us if you are still interested to attend, we will place you on the waiting list and notify you of an opening as soon as possible. When a reservation is cancelled more than 2 days before 1 April, a spot will be open to people on the waiting list. The system will send you an email confirming your space.
For all late cancellations (less than 2 days before 1 April) or no-shows, we do not have time to confirm waitlisted individuals. These spots will be given to people on standby. Your position on the waiting list has no influence on your standby position. They are two separate lists.
You must be physically present at the registration table at the Regency Ball Room of Hyatt Regency TST to add your name to the standby list. Standby list opens 30 minutes before opening session scheduled at 8:45 am, on a first-come, first-served basis.
There is NO fee to attend this symposium, but you must register to attend. (Registration is full.)
Please give us at least 2 days’ advance notice prior to 1 April, if you cannot attend the pre-booked Symposium so that we can release your seats to waitlisted individuals.
Please cancel your registration by replying to Eventbrite, or click HERE.
ACRP Oncology Research Symposium 2017 wishes to acknowledge the generous support of unrestricted educational grants from our sponsors. Industry support has been crucial to the success of this educational program.
About Conference Hotel: Hyatt Regency Hong Kong, TST
Hyatt Regency Hong Kong, Tsim Sha Tsui (TST) is located in the heart of the Kowloon business and entertainment district. With direct access to the MTR subway stations in Tsim Sha Tsui, the hotel features 381 guestrooms, three restaurants and one bar, outdoor pool, fitness centre, business centre, concierge desk plus meeting and conference facilities.
Regency Club, boasting spectacular views of Hong Kong, offers exclusive accommodation and a lounge where guests can enjoy daily complimentary continental buffet breakfast, coffee/ tea service, evening cocktails, complimentary use of meeting room in the lounge for one hour per day and more.
Hyatt Regency offers you a room rate starting from HK$1,886 (plus 10% service charge). Visit: Hyatt.
Hyatt Regency Club on the 23rd floor offers a gorgeous 180 degree view of the Hong Kong skyline. At around 8 PM each day, a laser light show called A Symphony of Light, is shown over the harbor which you can view directly from your room or at the Regency Club.
Oncology Research Symposium will be held in the Regency Ball Room of The Hyatt Regency Tsim Sha Tsui (18 Hanoi Road, TST, Kowloon). The hotel occupies the lower 24 floors of The Masterpiece, a large skyscraper in Kowloon, with the upper part of the building home to luxury condominiums. K11 shopping mall features a 340,000-square-foot, 7-storey shopping centre beneath the Hyatt Regency Hong Kong, Tsim Sha Tsui. There are restaurants on each floor of the mall, totaling over 20. Transportation from Hong Kong Airport is easy: Take the Airport Express Train to Kowloon Station, then board the free bus shuttle to the Hyatt Regency Tsim Sha Tsui (TST).
ACRP Training and Development is currently revising the curriculum of the prep course for the NEW Certification Exam which will go into effect in January, 2017. Check this site frequently for updates.
Questions about the prep course? Call: 1(703) 253-6269, Email: Arminda Valles-Hall <AValles-Hall@acrpnet.org>
ACRP Certification Exam Prep
IMPORTANT NOTICE: All attendees must bring to class the E6 GCP Guidance. The Guidance is available online: http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf
COURSE MATERIAL (請參閱課程)
- E6 GCP Guidance (GCP指導手冊): Below is the URL to download the E6 GCP Guidance for our class. Please print it if you don’t already have one. Please remember to bring this E6 GCP Guidance to class. To download the GCP Guidance, please click HERE. http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf
- DCO ( Detailed Content Outline): Please also bring with you the role specific manual, DCO (Detailed Content Outline). This material can be downloaded HERE. http://www.acrpnet.org/MainMenuCategory/Certification/How-To-Prepare.aspx
- LECTURE PowerPoint Slides: Handouts of lecture slides and additional course material will be distributed during class.
Instruction: In English. Q/A: English or Mandarin.
Registration & Breakfast: 8:30 AM to 9:00 AM
Lecture: 9:00 AM to 4:00 PM
To download the course brochure, please click here (下載課程簡介，請點擊此網址): Flyer_ACRP Certification Exam Prep Course
This ACRP prep course will be offered at two (2) locations for the March 2015 exam.
Location (1): Taipei – Saturday, January 24, 2015 (台北榮總, Taipei Veterans General Hospital)
台北榮民總醫院, 台灣台北市北投區, 石牌路⼆段 201號, 中正樓16樓，神經內科會議室。 The Conference Room, Department of Neurology, 16th Floor, Chiang Kai Shek Building, Taipei Veterans General Hospital, No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217, R.O.C.
Hotels by the Taipei Veterans General Hospital (住宿分別有天母、北投、士林可以選擇)
Location (2): Changhua – Sunday, January 25, 2015 (Changhua Christian Hospital) 彰化基督教醫院
50060台灣彰化縣彰化市建寶街20號 B1樓 彰化基督教醫院國際培訓中心
Changhua Christian Hospital
International Training Centre of Changhua Christian Hospital
Forte Hotel Changhua, B1F No.20, Jianbao St., Changhua City 50060, Taiwan
Please see Online Registration at the end of this announcement. Once your registration and your payment are complete, your Registration and Class Location will be confirmed by email. Should cancellation occur due to unforeseeable circumstances, ACRP will refund the participants.
Trainer: Benny Fok, PhD, CCRC (霍兆邦博士, 香港中文大學內科及藥物治療學系臨床藥理學科研究科學主任), Scientific Officer, Department of Medicine and Therapeutics, The Chinese University of Hong Kong. ACRP Approved Certification Exam Preparation Course Instructor.
Course Description: This ACRP Certification Exam Preparation classroom course provides guidance on how to prepare for an ACRP Certification exam (e.g., CCRA®, CCRC®, and CPI®) to candidates eligible to take the exam. Familiarize yourself with the format of the exam, tackle example questions, and conduct a personal gap analysis to ensure you are fully primed to earn your ACRP Certification.
This classroom course was prepared by ACRP experts exclusively for Chapters to offer locally, and is taught by a trainer approved by ACRP to teach this course. It includes PowerPoint presentations/hand-outs, interactive classroom exercises, discussions and question-and-answer sessions. No contact hours are offered.
Course Learning Objectives:
(1) Be able to list and use the benefits of certification to drive their exam preparation efforts
(2) Be familiar with the question-style and layout of ACRP’s Certification exams, including how to approachtheir multiple-choice format
(3) Be able to identify and describe at least three strategies for preparing for ACRP’s Certification exams
(4) Be able to use and reference the five relevant guidelines used to create the ACRP’s Certification exams:
- ICH E2A—Safety Definitions
- ICH E6—Good Clinical Practice
- ICH E8—General Considerations for Clinical Trials
- ICH E9—Statistical Principles for Clinical Trials
- The Declaration of Helsinki
(5) Be able to assess their individual level of readiness by practicing exam questions based on the Detailed Content Outline (DCO) under training conditions (NOT exam conditions)
|8.30AM||Registration Sign-in and Breakfast|
|9:00–9.15||Welcome and Introduction|
|9:15–11:00||Module 1: Objectives, Agenda, Introduction to Certification|
|11:15–12:15||Module 2: Overview of the 5 Relevant Guidelines|
|1:00–2:30||Module 2 Continued: Overview of the 5 Relevant Guidelines|
|2:45–3:45||Module 3: Practice Questions|
|3:45–4:00||Questions and Answers, Adjourn|
Target Audience: Eligible candidates for the CCRA®, CCRC®, and/ or CPI® ACRP Certification Exam.
About ACRP Certification: Applications accepted: Applications for the March 2015 Certification Exam will end February 1, 2015. The next exam date will be September 2015.
2015 Test Dates:
Spring – Feb 26 to March 21, 2015
Fall – Sept 9 to October 3, 2015
2015 Test Sites:
Beijing, Shanghai, Nanjing, Xian, Fuzhou, Guangzhou, Hong Kong, Malaysia, Singapore, Taipei (2 locations), and Kaohsiung. For more test sites and further details, please visit: https://www.prometric.com/en-us/clients/acrp/Pages/landing.aspx
ACRP Certification, administered by the Academy of Clinical Research Professionals (the Academy), is the formal recognition of clinical research professionals who have met eligibility requirements and demonstrated proficiency of specific knowledge and job‐related skills by passing a standardized exam.
ACRP Certifications are relevant for all research studies involving human subjects, including, but not limited to, drug, device, and biologic studies. Earning and maintaining your credential demonstrates that you have achieved the clinical research profession’s “trusted mark of excellence in clinical research”. This career milestone validates your clinical research knowledge and skills, and the ability to apply those in your daily work.
The CCRA®, CCRC®, and CPI® programs are accredited by the National Commission for Certifying Agencies (NCCA).
For questions about ACRP Certification: Please contact: firstname.lastname@example.org
Questions About Certification Benefits, Requirements, and Preparation: http://www.acrpnet.org/MainMenuCategory/Certification.aspx
Online Registration for the ACRP Certification Exam Prep Course
The online registration is now closed. Thank you.
Please check back often for more upcoming events.
如你需要 ACRP 邀請函，請電郵 (如你需要 ACRP 邀请函，请电邮)： email@example.com
ACRP 研討會詳情 (ACRP 研讨会详情): https://acrpcap.org/2014/06/12/acrp-china-asia-pacific-clinical-research-symposium-2014/
Click 2014 Symposium Program_V13 to download a printable program brochure.
ACRP 2014年度 中國及亞太區
Clinical Research Symposium 2014
Evolving Challenges of FDA & CFDA: Multilateral
Collaboration for the Industry & Regulatory Stakeholders
Symposium Date: Saturday, November 8, 2014
Attendees Check-in: Start at 8:15 am
Symposium: 9 am to 4 pm (Lunch from Noon to 1 pm)
Conference Hotel: Hong Kong Sheraton Hotel & Towers 20 Nathan Road, TST, Kowloon, Hong Kong, +852 2369 1111
Official Language: Presentations in English Discussions: English & Chinese
REGISTRATION IS NOW CLOSED.
Invitation Letter for Visa Application: Please email ACRPAsiaPacific@gmail.com
Date: Saturday, November 8, 2014, from 9 am to 4 pm (Breakfast starts at 8 AM.) Conference Hotel: Hong Kong Sheraton Hotel & Towers 20 Nathan Road, Tsim Sha Tsui (TST), Kowloon, Hong Kong, Click HERE for hotel web site. Hotel Booking: ACRP Group Rate is HKD $2125 per night for the block of rooms reserved for ACRP, available on a first come first served basis. To book your hotel room, please specify ACRP conference and email: RES.HongKong@sheraton.com . Enquiry: firstname.lastname@example.org Other Hotels: Kowloon Hotel, opposite HK Sheraton Hotel. (Rate is around HKD $1500 per night) , 19-21 Nathan Road, TST, Kowloon. Hong Kong. E-mail: email@example.com Tel: (852) 2734 3777. Web: http://www.harbour-plaza.com/kowloon/Index-en.htm
Morning Session 9:00 – 12:00, Saturday November 8, 2014
Best Regulatory and Development Practices – FDA, CFDA, and Industry Perspectives
Chair: Shaoyu Chen (陈少羽律师), Partner; Managing Director, China Food and Drug Practice, Covington & Burling LLP, Beijing http://www.cov.com/schen/ Chief Compliance Counsel, GE Healthcare China (2010-2011), Beijing, China Senior Counsel, Amgen (2006-2010), Thousand Oaks, California Assistant Chief Counsel, U.S. Food and Drug Administration (2000-2004), Maryland Bio: http://www.cov.com/schen （履历）
Quality of clinical trials is deemed paramount by the regulatory agencies for the protection and welfare of human subjects and patients. As more and more global trials have moved from the West to the East, especially to China, CFDA as well as the FDA have geared up their monitoring and regulatory effort. This session presents several practical considerations from CFDA/CDE experts and their point of view about the China clinical studies, as well as some practical experience from China’s local industry.
Strategy in Drug Development – From Roche Perspective Dr. Qinyong Dai Medical Director, Roche Hong Kong Limited Current Regulatory Practice in China The certification and registration of medical products with the CFDA can be an extensive and drawn-out process. A large number of documents, specifications and reports must be provided and intensive on-going communication with the certification bodies and testing laboratories is needed. Conducting the registration from overseas can be more difficult due to communication problems and the changes that may arise regarding the requirements of the regulatory bodies. Get informed about the CFDA certification process and all its single steps by an experienced industry insider.
- China Regulation System
- China Regulatory Authority
- China IND & NDA
- Communication with Health Authority
- China GCP & Clinical Trial
- Traditional Chinese Medicine Registration in China
Wendy Yan, MBA, Senior Vice President, Head of Regulatory Affairs, BeiGene (Beijing), Global Regulatory Strategist (2010-2014), Regulatory Affairs Director for China (2008-2010) Bayer Healthcare Responding to the Evolving Regulatory Environment Shaoyu Chen, LLB, JD (Bar Admission: District of Columbia) Partner; Managing Director China Food and Drug Practice Covington & Burling LLP, Beijing Noon to 1:00 Lunch (Ming Room I & Ming Terrace)
Afternoon Session 1:00 – 4:00 , Saturday November 8, 2014
Key Factors on Improving the Efficiency of Clinical Trial Study Quality and Analysis
Chair: Professor Benny Chung-Ying Zee, PhD (徐仲锳教授), Assistant Dean (Research), Professor/Head Division of Biostatistics, Director, Centre for Clinical Research & Biostatistics, Faculty of Medicine, Chinese University of Hong Kong
Biostatistics informs the Food and Drug Administration’s regulatory decision-making processes for premarket review of investigational drugs and devices and post-marketing surveillance of medical products, including decisions to require safety labeling changes and withdraw approval.
Dr. Wenjun Bao, Chief Scientist and R&D Manager for JMP Life Sciences of SAS Inc.
How GCP Impacts the Medical Product Review and Approval Decisions: GCP (human studies covered by an IND or IDE) and product applications (510k/PMA/NDA) for marketing approval
Chair: Dr. C K Kwan, MB, ChB, FRCR, FHKCR, FHKAM, CPI, MPM (關仲江醫生), Specialist in Clinical Oncology, Queen Elizabeth Hospital, Hong Kong
- Patient Safety: Principles and practice – An overview from the FDA Consumer Safety Officer
- Bioresearch Monitoring Program (BIMO) – the protection of research subjects and the integrity of research data in support of marketing approval.
- Recent trends in BIMO inspections of clinical investigators, IRBs, sponsors, and CROs.
- Key strategies for responding to FDA 483s and Warning Letters.
- FDA guidances & the regulation maze: practical considerations for the developers and manufacturers of electronic medical products and health monitoring devices.
Francis Eng, Assistant Director FDA China Office, Shanghai
Continuing Medical Education & Professional Development Accreditations:
Five CME and ACRP contact hours have been applied for through ACRP Global Headquarters. Membership is not required for online registration/application of contact hours. Updated information will be posted upon approval.
Please select one of the 3 methods to register for the ACRP clinical research symposium. Please register early to reserve your space. Deadline for online / wire / mail registration: Oct. 31.
(1) Online registration (Due to Singapore regulations, Singapore users please use Option 2 or 3.) To register online, please click on the appropriate Buy Now button below.
Registration fee is USD $100 :
Discount for a Group > 3: Please register and pay online for 3, add the name of the 4th person in “Instructions from Buyer", and email: Info@acrpcap.org
(2) Register by EMAIL and Pay Fees by Electronic Transfer:
Please wire remittance to: Bank of Communications, Hong Kong. Account No. 027 578 93016220, Account Name: Association of Clinical Research Professionals (Please do not use abbreviations.)
(3) Mail your contact information ( name, address and email address of each attendee) and a crossed cheque with the proper amount of registration fees to: Association of Clinical Research Professionals, GPO 7762, Central, Hong Kong
PROPER IDENTIFICATION IS REQUIRED. Please bring your email confirmation to the event.
|Terms and Conditions1. Registration is confirmed only upon receipt of payment. All successful registrations will receive a confirmation from ACRP-China & Asia Pacific Region via e-mail. ACRP reserves the final right of decision if there is any dispute.Cancellation Policy: No refunds are made upon confirmation. Substitutes are acceptable with written notice to ACRP-China & Asia Pacific Region at least 3 days prior to the event date of November 8, 2014.|