The five new International Identification of Medicinal Product (IDMP) standards are expected to be finalised and published by the International Organization of Standardisation (ISO) by the end of 2012. Implementation of these standards in the area of pharmacovigilance is further defined in the Commission Implementing Regulation (EU) 520/2012. The IDMP standards were developed in response to a worldwide demand for internationally harmonised specifications for exchanging medicinal product information in a robust and reliable manner. IDMP is one of a group of five standards, which together provide the basis for the unique identification of medicinal products.
The IDMP standards support the regulation of medicines and pharmacovigilance including Individual Case Safety Reports (ICSR). IDMP supports the activities of medicines regulatory agencies worldwide by jurisdiction.
Furthermore, under eHealth Governance Initiative (eHGI) semantic and technical interoperability has been identified as a key priority for modern healthcare delivery.
In the context of the international harmonisation activities, ICH is aiming to reach step 2 for public consultation of the M5 IDMP Implementation Guide (IG) in the next months. As per agreement with the ICH Steering Committee, the electronic submission of information on medicinal products and substances will be based on the Health Level 7 (HL7) Structured Product Labeling (SPL) IDMP messaging format, a major step forward in the international harmonization activities.
The course will provide important news on the eHealth Network activities and the challenges in semantic and technical interoperability of information on medicinal products. Data elements and message specifications as well as definitions of concepts for key terminologies in accordance with the ICH M5 IG will be further explained. The use of HL7 SPL IDMP Common Message Element Types (CMETs) will also be outlined in detail.
Furthermore, the Information Day will provide a forum to update stakeholders on the implementation activities in the context of the new pharmacovigilance legislation, more specifically, Article 57(2), second subparagraph of Regulation (EC) 726/2004. This will also include new aspects on maintenance of information on medicinal products.
Who Should Attend
- Regulatory affairs staff of pharmaceutical companies
- Representatives of IT departments of medicines regulatory authorities, pharmaceutical companies and service providers
- EU Qualified Persons responsible for Pharmacovigilance (EU QPPVs)
- Pharmacovigilance staff of pharmaceutical companies and medicines regulatory authorities
- Medicinal product management software vendors
- Sponsors of clinical trials
At the conclusion of this course participants should be able to:
Understand the ongoing international standardisation work on IDMP
Understand the e-health network activities and the ongoing work towards addressing interoperability challenges related to medicines
Recognise the main new features of the future IDMP messaging specifications
Prepare medicines regulatory authorities in the EU, IT vendors and pharmaceutical companies for the implementation of the new IDMP standards and adaptation of their regulatory product management and Pharmacovigilance systems
Understand the maintenance requirements for the electronic submission of medicinal product information by marketing authorisation holders, in compliance with the Article 57(2) provisions of Regulation (EC) 726/2004.
- e-health and interoperability challenges related to medicinal products
- Key principles of the ICH M5 IDMP Implementation Guide
- Use of HL7 SPL IDMP CMETs for the electronic exchange of information on medicinal products and substances
- Article 57(2) and maintenance of information on medicinal products by marketing authorization holders
- Questions and Answers on Article 57(2) implementation
- Industry perspective on Article 57(2) and ISO IDMP standards implementation
Kuechengasse 16, Postfach
4002 Basel, Switzerland
Phone: +41 61 225 51 51
Fax: +41 61 225 51 52
Hotel & Travel
Attendees have to make their own reservation.
Recommended hotel close to the EMA:
Hilton London Docklands Riverside
265 Rotherhithe Street,
London , SE16 5HW,
Telephone: +44 (0)20 7231 1001
Fax: +44 (0)20 7231 0599
DIA was able to negotiate a special rate for a limited number of rooms:
Room rate is GBP 145.00 per room incl. breakfast excl. VAT. Rooms are distributed on a first come, first serve basis.
Please click here to book your accommodation and enter the corporate account number: 481223696.
The hotel is situated opposite of Canary Wharf conveniently connected by a
shuttle boat. The landing stage is in walking distance to the EMA (2 min).