Wednesday, 24 October 2018
3:00-7:00 pm EST
The Conference Center at Waltham Woods
860 Winter Street
Waltham, MA 02451
Don’t miss this unique opportunity to engage with regulatory and quality colleagues from your region for an in-depth exploration of major restructuring at the China Food and Drug Administration (CFDA.) Our esteemed speaker, subject matter expert, CEO of ChinaMedDevice, Grace Fu Palma, just returned from a CFDA meeting in China. She will provide an overview of major restructuring at CFDA and other 2018 updates. This half-day program will include three sessions, each targeted to regulatory, quality and CRO professionals.
Scheduled presentations include:
- CRO Update: Overview of Recent Clinical Requirement Changes and Looking Ahead to 2019
- Clinical Evidence Requirements
- Clinical Trial/Evaluation
- International Clinical Data
- Multi-Center Trial
- Quality Update: QMS and Post-market Compliance Changes
- Overseas Inspections
- Summary of History Lessons
- Tips and Processes to Prepare for Oversees Inspections
- Regulatory Update: Pathways to Foreign Companies
- Innovation, Special Zones and Type Testing
- Legal Registration Holder vs. Contract Manufacturing
- Acceptable International Reports vs. Mandated Local Testing
This event is brought to you through a collaborative effort from the RAPS Boston chapter and the ASQ New England Discussion Group of the Biomedical Division, and is intended to encourage knowledge sharing and community development among regulatory and quality professionals in the New England region. A full dinner buffet will be provided for all attendees. Attendees can claim four RAC recertification credits or 0.5 ASQ RU/CEUs.
ASQ members, contact Pamela Goldstein for a registration discount code.
Grace Fu Palma, a Sino-US MedTech veteran, founded ChinaMedDevice (www.ChinaMedDevice.com) to provide turn-key solutions for western medical device/IVD/combination products’ companies to enter China with regulation and commercialization services. With 20+ years of experience driving global product strategy, commercialization, partnerships, and China operations for both large multinationals and startup companies, she has held a variety of management positions in marketing and operations at multinationals and start-ups. She founded the Chinese American Heart Association in 2005. She has been a speaker at national regulatory meetings as well as a column contributor for US regulatory news and journals.
About China Med Device
China Med Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD and combination-product companies to enter China. Our NMPA (CFDA) regulatory services include: regulatory strategy, RA, clinical evaluation, clinical trial, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership, distribution qualification and management. We are a NMPA (CFDA) certified legal agent. With offices in Boston and Beijing, we can service our clients 24/7.