Gravitate-Health EU-China Workshop

22nd August 2022

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.

Challenges and solutions for electronic labeling medications in the EU and China: collaboration opportunities is the title of the Gravitate-Health EU-China Workshop that will be held during the 3rd EU-China Health Summit on Medical Innovation and Technology Transfer taking place from 23rd to 27th of August 2022.

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.

Program

08:00 (CET)/14:00 (CN) Welcome and introduction to the session

Rie Matsui, Catherine Chronaki

08:05 (CET)/14:05 (CN) 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

Abstract: There are various labeling regulations all over the world. In general, two types of labeling documents exist, one is the healthcare professionals and the other is the patient centric labeling. Much of the current focus around labeling is about the content and little attention has been paid to how the label is being accessed, used, understood, and adhered to in real life settings. We need to shift our mindset. There are three key related issues for the patients, accessibility, understanding, and adherence. Electronic product information will improve the accessibility and understanding of product information, thereby enhancing adherence to medicines and patient outcome. Due to the COVID-19 pandemic, various electronic labeling initiatives have been accelerated worldwide following the full digitalization movement in healthcare and pharmaceuticals fields. 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. The presentation will share the landscape of e-labeling initiatives and patient centric labeling all over the globe, and the current labeling situation especially the differences between China and Europe.

08:30 (CET)/14:30 (CN) 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

Abstract: The product information (PI) of an EU medicine includes the package leaflet for patients and the summary of product characteristics for healthcare professionals. These documents accompany every medicine authorised in the EU and explain how the medicine should be used and prescribed. While today the PI is generally provided by regulators in pdf format, and the package leaflet included as a printed copy in the medicines pack, there is a need to provide a semi-structured electronic format of PI (ePI) for EU medicines. Harmonised implementation of ePI in the EU will widen the dissemination of up-to-date medicines information to patients and healthcare professionals at the point of need. ePI will increase accessibility of medicines to users with diverse abilities. In addition, ePI offers opportunities to enable administrative efficiencies in handling of product information. EU regulators have adopted the EU ePI Common Standard, based on the global FHIR standard for healthcare applications, paving the way for harmonised implementation. The presentation will describe the road to ePI implementation and progress in building the tooling and business processes needed to introduce ePI into EU regulatory processes. Expansion of use of ePI and future evolution to facilitate advanced use cases will also be discussed.

08:50 (CET)/14:50 (CN) Challenges of delivering structured ePI (electronic labeling)

Fakhredin Sayed Tabatabaei, CBG-MEB, The Netherlands

Abstract: The goal of developing an electronic version of Product Information (PI) is to improve the shortcomings of paper version sensed in the 21st century health system. Although the definition of PI is relatively straightforward, the definition of ‘electronic’ could be misleading. In fact, any format beyond paper version may be considered electronic. However, formats such as PDF, Word or other free text files do not deliver the benefits that are expected from the electronic Product Information (ePI). In addition to the electronic characteristic of ePI, there are a few essential elements still to be taken into consideration. The first unmissable criterium is ‘Structured’ format, meaning that ePI has to contain some structured data elements (e.g. consistent, fixed headings and controlled vocabularies), although some unstructured elements (e.g. free text and graphics) may still be present. Nonetheless, inconsistencies and divergence of the information are part of paper version shortcomings, which cannot be resolved only by an structured electronic format. For this reason, the structured data elements have to be ‘Coded,’ in order to facilitate standardization. Last, but not least, those structured and coded elements need to be ‘Connected’ to some high-level data sources. This will facilitate seamless harmonization of product information at regional and international level, and ultimately deliver the maximum benefit to the health system and ultimately to the patients.

09:05 (CET)/15:05 (CN) HL7 FHIR ePI Implementation Guide

Jens Kristian Villandsen, Business Unit Leader at Trifork | Chairman of the board @ HL7 DK

Abstract: The Gravitate-Health initiative has launched the ePI/eLabeling Project, under the HL7 FHIR accelerator, in an effort to create a global standard consistent to EMA’s ePI common standard specification. This presentation will describe the current status of the HL7 FHIR implementation guide and relate it to developments around the world.

09:25 (CET)/15:25 (CET) break

09:35/15:35 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 (CET)/10:00 (CN) Survey results from the Chinese PI project from Tsinghua university

Jason Chen, Pfizer & Wenya Wang, Tsinghua university

In China per regulation there is only one labeling document (also called ‘product information’) approved for a drug. This PI is supposed to be used by both healthcare professionals and indicated patients. Although there is the general requirement per labeling regulation (Order 24) that fluent easy language should be used in authorizing the document for better understanding. However, in reality it may not be the case. There is always PI related enquiries and complaints from the patients. To know the overall feedback an on-line survey was designed and conducted in China. There are totally 17 questions in this survey, including 4 demographic questions, 13 PI related questions related to how PI is used, how much PI is understood, and what future labeling is expected ie patient labeling or e-labeling. By end of date, totally 7000 subjects’ responses were collected which mainly come from Beijing and Shenzhen (two tier 1 cities). Among them 6953 responses were finally analyzed. In this presentation we are going to share some of the survey results.

10:15 (CET)/16:15 (CN) Process and experience sharing about digitalized and integrated doctor and patient management

Kitty Jin, Vice president, Medlive

Abstract: Medlive utilized the deep understanding of 310 million doctors in past 26 years, create a new module about digitalized patient management. Based on the core element of patient management—patient education and patient follow up, create a convient digital patient management tool, use multipal media to deliver the patient education material in public and private way. By linking the doctor and patient, patient’s understanding about disease, diagnose and treatment has improved, and improve the patient compliance. In addition, doctors’ scientific need, clinical need, and branding need have also been considered, and realize a win-win solution for both doctor and patients.

10:30 (CET)/16:30 (CN) Discussion

10:55 (CET)/16:55 (CN) Closing remarks

11:00(CET)/ 17:00 (CN) End of Workshop

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