Pharmaceutical Working Group: Presentation and Discussion on Drug Administration Law Go back »
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Time2019-10-10 | 09:30 - 11:30
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Venue:Aredia, Novartis Pharma
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Address:
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Fee:Members: Free
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20191010 Pharma Working Group Meeting Minutes Attendees only |
Dear Pharmaceutical Working Group Members,
We are pleased to invite you to attend the next Pharmaceutical working group meeting which will take place on Thursday 10 October at 9:30-11:30am at ROPES & GRAY LLP Shanghai office and Novartis Beijing office via videoconference facility.
After close to 3-years of deliberation at the National People’s Congress, the new Drug Administration Law will be effective as of December 1, 2019. During our next working group meeting, Katherine Wang, Partner of Ropes & Gray LLP and the former head of AstraZeneca’s legal department in the Asia-Pacific region, will give a 45-minutes presentation on the highlights of the new Drug Administration Law and examine their impacts on companies’ market access strategies in China. Katherine will also review some outstanding questions which the new Drug Administration Law does not clearly answer, and share her assessment with the working group members.
Please note this session is in Chinese only and no English translation will be provided.
Please find the meeting agenda and the speaker's bio as below:
Agenda:
09:00-09:30 Registration
09:30-09:40 Welcome remarks
09:40-10:25 Presentation on Drug Administration Law by Katherine Wang, Partner of Ropes & Gray
10:25-11:20 Q&A and free discussion
11:20-11:30 Wrap up
Speaker Bio:
Katherine Wang, Partner, Ropes & Gray LLP
Katherine Wang is a partner of Ropes & Gray LLP’s life sciences group. Widely regarded as a leading life sciences regulatory lawyer in China, Katherine assists pharmaceutical, biotechnology, and medical device companies on a wide range of matters, including early-stage discovery, product registration, regulatory/GxP compliance, pricing, reimbursement, clinical studies, promotional practices, and product safety issues. Katherine provides day-to-day counseling on issues that life sciences companies face in relation to their interaction with agencies including the National Medical Products Administration (NMPA, formerly the CFDA), the National Health Commission (NHC) and the State Administration of Market Regulation (SAMR), among others. She also assists institutional investors and corporate clients in structuring transactions and conducting regulatory due diligence, including good laboratory practice (GLP), good clinical practice (GCP), good manufacturing practice (GMP) and pharmacovigilance, on investment targets and prospective business partners in China.
Before entering into private practice, Katherine served as the head of AstraZeneca’s legal department in the Asia-Pacific region. In this role, she advised on critical strategic and operational initiatives to ensure legal compliance and realization of business objectives. She was also responsible for cross-functional intellectual property enforcement and anti-counterfeiting efforts.
Registration:
If you would like to attend this meeting, please register online or with Ms. Xinyi Xie at sh_govaffairs_a@europeanchamber.com.cn (in cc) indicating which office you would like to attend no later than Wednesday 9 October, COB. Please kindly note the pharmaceutical working group is a closed group and open to pharmaceutical manufacturers only. Therefore, registration is required and walk-in may not be accepted.
As always, we welcome your suggestions for agenda, topics and possible speakers for future meetings. Should you have any other questions, please feel free to contact us.
Best regards,
European Union Chamber of Commerce in China
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For more information about the Pharmaceutical Working Group or the European Chamber in general, please contact Ms. Helei Fu (hlfu@europeanchamber.com.cn).
Speakers
Ms. Katherine Wang
Ms. Katherine Wang
Katherine Wang is a partner of Ropes & Gray LLP's life sciences group. Widely regarded as a leading life sciences regulatory lawyer in China, Katherine assists pharmaceutical, biotechnology, and medical device companies on a wide range of matters, including early-stage discovery, product registration, regulatory/GxP compliance, pricing, reimbursement, clinical studies, promotional practices, and product safety issues. Katherine provides day-to-day counseling on issues that life sciences companies face in relation to their interaction with agencies including the National Medical Products Administration (NMPA, formerly the CFDA), the National Health Commission (NHC) and the State Administration of Market Regulation (SAMR), among others. She also assists institutional investors and corporate clients in structuring transactions and conducting regulatory due diligence, including good laboratory practice (GLP), good clinical practice (GCP), good manufacturing practice (GMP) and pharmacovigilance, on investment targets and prospective business partners in China.
Before entering into private practice, Katherine served as the head of AstraZeneca’s legal department in the Asia-Pacific region. In this role, she advised on critical strategic and operational initiatives to ensure legal compliance and realization of business objectives. She was also responsible for cross-functional intellectual property enforcement and anti-counterfeiting efforts.
Representative Clients and Matters
• Routinely advises foreign pharmaceutical companies on their China entry strategies, particularly issues relating to the selection of regulatory pathways, availability for fast track approvals, IP protection and regulatory exclusivity, and relationships with local regulatory agents and distributors.
• Routinely advises multinational pharmaceutical and medical device companies in matters relating to their clinical studies in China, particularly concerning Chinese National Human Genetic Resources Administration office approvals, localization of clinical study agreement templates, clinical trial authorizations, informed consent, waiver for registration studies, use of foreign clinical study, data in regulatory applications, investigator-initiated studies, study insurance, privacy protection, dealings with CROs, research injuries, and dispute resolution.
• Advised several multinational pharmaceutical and medical device companies on issues associated with localization of product manufacturing in China, including the establishment of manufacturing facilities, type testing requirements for locally made products, possibilities for clinical trial waivers, and product approval pathways.
• Advised several leading biopharmaceutical companies on biosimilar strategies in China.
• Advised several multinational pharmaceutical and medical device companies on market access issues in China, particularly related to pricing, reimbursement, tendering, and patient assistance programs.
• Assisted several multinational pharmaceutical companies in matters relating to the conduct of secondary medical research in China, e.g. collection, use, import and export of human biological samples, construction of biobanks through collaborations with Chinese hospitals, and radioactive labeling of human biological samples in China.
• Routinely advises multinational pharmaceutical and medical device companies on promotional practices, particularly off-label promotion, pre-approval communication and direct-to-patient communication.
• Advised the company on the regulatory requirements for the practice of medicine and the compliance issues related with the supply of medical instruments and equipment under the collaboration.
Honors & Awards
• Chambers Asia: Asia's Leading Lawyers in life sciences (2011 - 2019)
• Chambers Global: The World's Leading Lawyers for Business (2015 -2018)
• Legal 500 Asia Pacific: Leading Individuals in life sciences (2019)
• Financial Times: Asia-Pacific Innovative Lawyers (2018 finalist)
• Asian Legal Business’ Client Choice Top 20 Lawyers in China (2016-2019)
• Lexology Legal Influencer for Healthcare and Life Sciences - Asia-Pacific (2018)
• Who's Who Legal: Life Sciences (2015-2016, 2018-2019)
• China Business Law Journal: The A-List of China’s Top 100 Lawyers (2016)
Published Work
• Co-author, “Building a “Healthy China” Through Innovation and Compliance,” Ropes & Gray (September 20, 2019)
• Quoted, “China Widens MAH Scheme To Medtech As Consumables Face Price Cuts,” Medtech Insight (September 16, 2019)
• Author, “China proposes major changes to pharmaceutical regulations,” Asia-Pacific Biotech News (June 12, 2019)
• Quoted, “No Room For Error: China Proposes Hefty Fines On Quality Violations In Drug Law Overhaul,” Pink Sheet (May 20, 2019)
• Author, “Updates from China’s Life Sciences Industry,” Asia Pacific Biotech News (February 11, 2019)
• Quoted, “Random Checks Now Routine: China To Inspect Your Factories Near And Far,” The Pink Sheet (January 16, 2019)
• Quoted, “Industry Insight: APMTF2018 sound-bites - China reforms and opportunities for market access,” FirstWord MedTech (October 10, 2018)
• Quoted, “Attorneys Urge Chinese Regulator to Engage More With Industry,” International Devices & Diagnostics Monitor (September 7, 2018)
• Co-author, “Public Private Collaboration to Advance Medtech Regulation Reform,” (September 5, 2018)
• Quoted, “China Simplifies Device Registration Requirements,” FDA News (August 31, 2018)
• Author, “China’s New Medical Device Regulations Bring Big Changes,” Law360 (July 23, 2018)
• Profiled, “Ten Pioneers of New Legal Thinking: From Access to Justice to Spin-Off Ventures,” Financial Times (June 7, 2018)
• Co-author, “What Companies Need to Know About China’s New Market Regulator,” Law360 (April 12, 2018)
• Quoted, “Goodbye CFDA, Hello MRA: China Overhauls Regulatory Bodies,” Pink Sheet (March 13, 2018)
• Quoted, “CFDA Issues Guidelines for Using Foreign Device Trial Data,” International Devices & Diagnostics Monitor (January 22, 2018)
• Quoted, “China FDA to Require Registration, Training of Medical Reps,” International Devices & Diagnostics Monitor (January 8, 2018)
• Co-author, “China's FDA Reform Will Encourage Life Science Innovation,” Law360 (November 15, 2017)
• Quoted, “China Cuts Drug Approval Timelines, Sets Tough Penalties On Individuals Violating R&D Or Safety Rules,” Pink Sheet (November 1, 2017)
• Quoted, “China's New Device Catalogue Makes Significant Classification Changes,” FDAnews Device Daily Bulletin (October 3, 2017)
• Quoted, “Medtech Advised To Prepare For Significant Updates In China’s Classification Catalogue,” Medtech Insight (September 8, 2017)
• Quoted, “Clinical Data Forgers Face Harsh Punishment in China,” Pink Sheet (August 17, 2017)
• Co-author, “Every Single Step Counts for a Journey of a Thousand Miles,” White Paper published with McKinsey & Co. (July 2017)
• Co-author, “Life Sciences: Product Regulation and Liability in China,” Lexology (January 2017)
• Co-author, “Coping with Evolving Regulatory Challenges,” White Paper published with McKinsey & Co. (August 2016)
• Co-author, “China’s medical device market: New Policies, Higher Stakes,” white paper published with McKinsey & Co. (September 2015)
• Co-author, “Unanswered Questions: China’s New Pharma Advertising Rule,” Law360 (August 2015)
• Co-author, “New China FDA Guidance May Speed up Device Approvals,” Law360 (June 2015)
• Author, “Biosimilars are regulated differently in China,” Pharma DJ (May 2015)
• Author, “China Liberalizes Drug Pricing Control,” China Corporate Law Service (May 2015)
• Co-Author, Chambers Legal Practice Guide: China Life Sciences (2015)
• Co-Author, PLC: Medical Product Regulation and Product Liability in China (2015)
• Author, “Major Changes Come to China's Medical Device Industry,” Law360 (April 2014)
• Co-Author, “China Anti-Bribery Rules Raise Questions for Life Sciences,” Law360 (February 2014)
Presentations & Speeches
• Speaker, “Current Issues in Technology Transfer,” Ropes & Gray Roundtable (November 2, 2018)
• Speaker, “Regulatory Challenges and Solutions for Mobile Health Sector in China,” Health China and the New Norm: Mobile Health Summit (May 2015)
• Speaker, “Biologics v.s. Biosimilars: Four Questions for 2015,” Chinabio Partnering Forum (April 2015)
• Speaker, “Pharmaceutical Industry Code of Practice In and Outside of China,” Medical Affairs Essentials (November 2014)
• Speaker, “Riding the New Wave: How to Prepare Your Life Sciences Company for Compliance and Success in the Face of China's Recent Regulatory Changes,” Ropes & Gray West Coast Lunchtime Legal Briefing Teleconference (January 2014)
Education
• LLM, 2000, Harvard Law School
• LLM, 1999, National Taiwan University, Taipei
• LLB, 1997, National Taiwan University
Bar Admissions
• New York, 2002
Languages
• Chinese (Mandarin)