The Gravitate-Health project organises the workshop “Challenges and solutions for electronic labeling medications in the EU and China: collaboration opportunities” at 3rd Europe-China Health IT Summit. The workshop takes place on 24th August at 8 am CET.

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. In this session, we 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, we will discuss the current technology landscape in medical informatic area 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.

Speakers

Co-Chairs

• 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

Speakers

• Rie MATSUI, Senior Director, Head of Regional Labeling for APAC, Global Regulatory Affairs, Pfizer R&D Japan, Landscape of current trends of product information (labeling) across regions
• Juan GARCIA-BURGOS, Head of Public and Stakeholder Engagement Department, European Medicines Agency, Electronic product information in the European Union (EU): the road ahead
• Fakhredin SAYED TABATABAEI, Medicines Evaluation Board Agency (CBG-MEB) NL, Challenges of delivering structured ePI (electronic labeling) 
• Jens Kristian VILLADSEN, Business Unit Leader at Trifork, Chairman of the board @ HL7 DK, HL7 FHIR electronic Product Information (ePI) Implementation Guide
• Lan ZHANG, Vice Director of national clinical test organization for medication, Chair for China alliance Pharmaceutical Federation, Intelligent Pharmacy promoting the rational use of drugs.
• Wenya WANG, Beijing Tsinghua Chang Gung Hospital, Tsinghua University, Survey results from the Chinese PI project from Tsinghua university
• Jing (Jason) CHEN, team lead of International Labeling Group at Pfizer
• Kitty JIN, Vice president, Medlive, Process and experience sharing about digitalized and integrated doctor and patient management

Comments -Discussion

• Lars LIDSKOLD, EFMI Institutions Officer, 

Zoom Meeting https://cesnet.zoom.us/j/99267387645?pwd=K2NqNkFmb2tYV3dLclBXWFpXQU9Wdz09

Meeting ID: 992 6738 7645, Passcode: 124752