♦ (Closed) ACRP-CAP Clinical Research Symposium 2014

ACRP-CAP Uncategorized

Click 2014 Symposium Program_V13 to download a printable program brochure.

  ACRP 2014年度 中國及亞太區  

臨床研究研討會 

美國FDA與中國CFDA合作論壇：行業及監管利益相關的跨界融合

醫療發展的新機遇

藥品註冊等產業熱點研討会

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: rebecca.yu@sheraton.com 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:    enquiry.klnh@harbour-plaza.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.

The efficiency of the whole clinical trial data process cycle of collecting, analyzing and reporting data was influenced by multiple factors.  This presentation will discuss the effort of data standardization, data quality control and assessment through risk-based monitoring and fraud detection, and the data analysis automation and visualization on the clinical trial study. Many industry insiders do not fully understand the recent guidelines from the FDA, ICH and other professional authority. A SAS specialist will discuss statistical analysis pertinent to ethics, litigation, and regulatory issues.

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.

REGISTRATION (CLOSED)

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.