TOWARDS A TRANS-ATLANTIC SOLUTION TO UNIVOCALLY IDENTIFY MEDICINAL PRODUCTS

Transcription

1 As Jos and others rightly pointed out: The workshop is about IDMP development, implementation, and maintenance along the life cycle of a medicinal product: To focus on expert input and exchange, learning together, developing ideas about the future To inform and to obtain reactions from trans-atlantic stakeholders on the options discussed/foreseen in the European Union and its member states as well as in the USA and Canada To inform each other on European and North-American implementations of eprescription, edispensation, epatient Summary etc. To consider to adapt and harmonise contents and processes where deemed useful by both sides of the Atlantic (and perhaps globally) To acknowledge each other s judgement on the use and usefulness of the IDMP suite of standards outside the core regulatory context To discuss the SDO landscape, its contributions to the challenges at hand, further collaboration options. TOWARDS A TRANS-ATLANTIC SOLUTION TO UNIVOCALLY IDENTIFY MEDICINAL PRODUCTS USA-EU Workshop FDA White Oak Campus, New Hampshire Av., Silver Spring, MD June 20-21,

2 Draft detailed agenda 08:00 Registration & coffee 08:30 08:40 09:00 09:15 Monday, June 20, 2016 (Day 1) Chair (morning): Vada Perkins Welcome Brief introduction of participants The European Union (EU) policy challenge: univocal identification of medicinal products (MPs) and substitution in cross-border healthcare settings Identification of medicines and the regulatory context EU xborder Healthcare Directive Exchange of patient data: electronic patient summary (incl. medication record), eprescription Member State cooperation, and eprescription Guidelines OpenMedicine challenges Identification Substitution Business case Roadmap 09:35 Coffee Break 10:00 The US policy context: univocal identification of medicines and the use of standards throughout the product lifecycle. Clinical Trials Assessment and Marketing Authorization eprescription and edispensing Pharmacovigilance USA FDA All European Commission (EC) representative, Washington, DC Karl asked again for name Answer by Gerald promised Karl A. Stroetmann, openmedicine Lonnie Smith, FDA Tammy Powell National Library of Medicine (NLM) John Klimek, NCPDP Tom Bizarro, First Databank 11:00 Trans-Atlantic regulatory cooperation and harmonisation - focus on IDMP History The mandate Objectives and process Cooperation with ISO (ISO IDMP suite) Achievements Results Global perspective Joan Blair, FDA 2

3 11:30 Plenum discussion All 11:50 Summary of the morning Vik Srivastava, rapporteur 12:00 Lunch 13:00 13:50 Chair (afternoon): Karl A. Stroetmann Identification and description of branded medicinal products the openmedicine approach ISO developments Consensus standards evolution ISO-IDMP suite openmedicine framework Needs from complementary use cases Gap analysis Framework OpenMedicine standards based identification and description enabling dispensing equivalent medicinal products Identifiers Identifying attributes set Descriptive attributes EU and USA harmonisation of content and message exchange for IDMP implementation openmedicine Christian Hay, openmedicine William Goossen, openmedicine José Teixeira, openmedicine Vada Perkins, FDA, USA Kevin Horan, openmedicine/ Health Products Regulatory Authority, Ireland 14:30 Coffee break 15:10 Implementing IDMP: The pivotal role of the PhPID (Pharmaceutical product identification) Open issues in defining and standardisation of the PhPID Production and maintenance Production: the algorithm generating the PhPID Distribution: global single point of access for all stakeholders Integration: API for integration into national drug databases Maintenance: mapping medications globally Specific multilingual challenges Sustainability provisions All three to coordinate & sort out detailsl Vada Perkins, FDA Paolo Alcini, FDA/EMA 3

4 16:00 Generating, Validating, Implementing & Distributing IDMP EU (EMA) ISO IDMP Task Force FDA Generating a PhPID Pharmaceutical data bases & software: cooperation and implementation challenges global harmonisation versus national regulatory idiosyncrasies Vada & Paolo to sort this out/reword /EU Vada Perkins, FDA Malin Jackobson, WHO-UMC Tom Bizarro, First Databank 17:00 Plenum discussion All 17:20 Summary of the afternoon Jos Devlies, openmedicine 17:30 End of day 1 19:00 Dinner 4

5 Tuesday, June 21, 2016 (Day 2) 08:30 Registration & coffee Chair (morning): Paolo Alcini EMA 09:00 Summary of day 1 and introduction to day 2 Chair/ Jos Devlies, openmedicine 09:10 Implementing IDMP in Canada a progress report Vik Srivastava, Canada 09:40 Added value of using IDMP in other domains 10:30 Coffee Break 11:00 Patient safety, clinical care and decision support Identification of medicinal products in clinical research/real world data Medication data in patient summaries Pharmacy information systems International Patient Summaries Round Table: Cooperation and impact on SDOs / global standardisation endeavours Whilst ISO standards are becoming mature, implementers work to meet IDMP as regulatory requirements, what does your SDO undertake to leverage these standards? NLM / RxNorm National Council for Prescription Drug Programs (NCPDP HL7 ISO/CEN CDISC Not available, NN by USA, or delete? Dipak Kalra, European Institute for Innovation through Health Data Devlies Jos, openmedicine John Klimek, NCPDP?? NN, (Vada) Christian Hay (Chair)?? probably not John Klimek NN? William Goossen Bron Kisler 11:50 Summary of the morning Karl Stroetmann 12:00 LUNCH Chair (afternoon): Kevin Horan openmedicine 5

6 13:00 Practical applications of implementing IDMP EU eprescription Guidelines, linking to EMA Art. 57 (2) data base, and IDMP Regulator view: update, harmonisation needs and expected benefits across the EU regulatory network a view from a small national agency Practical use case demonstration Benefits / Coordinator: Kevin Horan Jeremy Thorp, EU ehealth Network; NHS England Kevin Horan, Irish Health Products Regulatory Authority (HPRA) Isabel Lazaro, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) 13:45 Trans-Atlantic validation, roadmaps, and implementation planning openmed recommendations and roadmap EU/EMA EU Data Network Board (EUDNB) USA 14:45 Coffee Break 15:15 Vision, next steps for cooperation, global outreach (15 minute interventions) EMA perspective [EPRF (?) paper, international outreach?] FDA perspective Jos Devlies, openmedicine Vada Perkins, FDA Joan Blair, FDA not coming 16:00 Plenum discussion All 16:35 Summary of the afternoon, and overall workshop results José Teixeira, openmedicine 16:50 Thanks, farewell Third Expert Council Meeting, October 27, 2016 at EMA, London 17:00 End of day 2 TBD, FDA Jos Devlies, openmedicine Deadline for all presentations to avoid duplication, allow for coordination: Suggested deadline: Wednesday, June 15 6