Gravitate Health EU-China Workshop: Challenges and solutions for product information in the EU and China and collaboration opportunities
Join the Gravitate Health EU-China Workshop on Wednesday, August 24, 2022, 08:00-11:00 CET [14:00-17:00 CN]. Participation is open!
Speakers will share the landscape of e-labeling initiatives around the world, the most up-to-date ePI initiatives led by EMA and the current situation and challenges on product information in China and Europe. Also, the current technology landscape in medical informatic area will discussed, which will be linked to digital health and the innovative research project on product information from patient centric point of view in China and Europe. In the closing panel, the speakers will join the discussion on collaboration opportunities between the EU and China.
Background
A product information is a critical risk-minimization measure communicating benefit/risk and usage instructions. There are a variety of formats (paper, electronic) and types (patient, HCP) distributed according to national requirements. Also, there are differences of the products information not only contents, but also the template of the product information. Due to the COVID 19 pandemic, various electronic labeling initiatives have been accelerated worldwide following the full digitalization movement in health care and pharmaceuticals fields.
E-labeling improves the accessibility and understanding of medical product information, thereby enhancing adherence to medicines and patient outcomes. The availability of the up-to-date labeling on a publicly accessible website is an important first step in improving patient safety and trust in medicines. Eventual removing paper labeling from the commercial packs will improve efficiencies on reducing operational steps for inserting paper labeling in packs, and support environmentally friendly process. The adoption of e-labeling in a structured format enhances the user’s ability to navigate information on how to use, handle the product and to better understand safety information. In the future, e-labeling will be integrated with the wider digital healthcare system such as electronic medical record, electronic prescription, resulting to greater efficiencies, and opportunities lie within the healthcare sector.
Programme
Displayed in CET
08:00, Welcome and introduction to the session
Rie Matsui, Senior Director, Head of Regional Labeling for APAC, Global Regulatory Affairs, Pfizer R&D Japan
Catherine Chronaki, EFMI president, Gravitate-Health Interoperability Lead
08:05, Keynote: Landscape of current trends of product information (labeling) across regions
Rie Matsui, Senior Director, Head of Regional Labeling for APAC, Global Regulatory Affairs, Pfizer R&D Japan
08:30, Keynote: Electronic product information in the European Union (EU): the road ahead
Juan García Burgos, Head of Public and Stakeholder Engagement Department, European Medicines Agency
08:50, Challenges of delivering structured ePI (electronic labeling)
Fakhredin Sayed Tabatabaei, CBG-MEB, The Netherlands
09:05, HL7 FHIR ePI Implementation Guide
Jens Kristian Villandsen, Business Unit Leader at Trifork | Chairman of the board @ HL7 DK
09:25, Break
09:35, Keynote: Intelligent Pharmacy promoting the rational use of drugs
Dr. Lan Zhang, Vice Director of national clinical test organization for medication, Chair for China alliance Pharmaceutical Federation
10:00, Survey results from the Chinese PI project from Tsinghua University
Jason Chen, Pfizer & Wenya Wang, Tsinghua university
10:15, Process and experience sharing about digitalized and integrated doctor and patient management
Kitty Jin, Vice president, Medlive
10:30, Discussion
10:55, Closing remarks
11:00, End of Workshop
