This 2-day interactive training workshop on IDMP (Identification of Medicinal Products) is aimed at professionals in the pharmaceutical field who appreciate the importance in preparing for IDMP and want to make optimal use of the time left for implementation. Although the EU will likely apply a staged approach for IDMP implementation, this should not be interpreted as postponed activity but rather as an extension of the implementation time required.Download Programme
Irrespective of the finalisation of the implementation guidelines, IDMP requires awareness, ownership and need for change of business processes as well as software tools. The ISO IDMP standards themselves clearly indicate the magnitude of change required within pharmaceutical companies as well as health authorities. Health authorities have already published their needs which in turn will have impact within industry 1, 2, 3 . The pharmaceuticals industry must consider mirroring these needs to minimise future complications following regulatory updates.
Therefore, the lack of final IDMP implementation guidelines should not to be used as an excuse for delaying your strategy for handling the IDMP implementation processes. Due to the complexity and broad scope of the topic it is recommended to start developing frameworks for IDMP projects sooner rather than later. The effort will be significant; as will the gain in efficiency, transparency and ability to identify corrective and preventive actions (CAPAs).
The workshop will cover the practical aspects of IDMP implementation and the impact on the business processes and software tools. It is designed to be an educational environment where content focuses on actively engaging the topics presented. Instructors will lead break-out sessions and group collaboration to develop creative solutions that will allow participants to contend with the demanding work ahead.
Solution providers will present different practical software solutions and offer their knowledge to the participants.
The interactive training workshop will be most useful to those professionals with basic knowledge about IDMP who want to gain a more in-depth understanding about preparation for- and efficient approaches to IDMP implementation.
Call for Abstracts on Vendor IDMP Showcases
Deadline for submission: 9 October 2015
Adopting IDMP will have a significant impact on the business processes within pharaceutical companies.
Successful implimentation relies on smart and inventive software solutions.
Industry must stay informed about the latest trends and developments of software solutions supporting IDMP.
Sufficient time is allocated during the workshop for non-promotional showcases by software vendors.
Showacases should include
- The various views on the IDMP data
- Potential workflows within and across systems
- Search & reporting functionalities
- Integration with other systems
- Submission and exchange with health authorities
The showcases must be educational and not promotional. Participation in this event offers software vendors an opportunity to demonstrate their knowledge and subject matter expertise on IDMP though hands on engagement with participants. The intent of the showcase is to highlight software in development by the various software vendors, preferably by live demonstrations which reflect the interactive educational points of the training conducted.
A maximum of 7 showcase slots are available and limited to software vendors only.
The selection of showcases is up to the discretion of the organising committee and DIA.
The deadline for submitting abstracts is Friday, 9 October 2015, please send your abstract in word format to:
Who should attend?
- Professionals of Pharmaceuticals industry:
- Regulatory affairs/operations representatives
- Regulatory compliance specialists
- IT and support personnel
- Document and records managers
- Standards implementation specialists and associates
- Quality assurance and compliance professionals
- Validation and migration professionals
- Knowledge/IP professionals
- Labelling specialists
- Pharmacovigilance professionals
- CROs, CMOs and service providers
- Agency representatives (e.g. inspectors and reviewers)
At the end of this workshop participants will get insight into the following key topics:
- Various ways to approach IDMP implementation
- Semantic challenges and managing common terminology
- Generation and ownership of IDMP data on Medicinal Product
- Generation and ownership of IDMP data on substances
- IDMP as an opportunity for Business Excellence
- Difference and resemblance concerning IDMP and Master Data
- Must haves and nice to haves for a data quality framework
- Project charter for IDMP implementation
- Relevant tools and vendor knowledge bases