ISO IDMP is a legislative requirement. However besides the legal mandate ISO IDMP also allows substantial benefits with regards to optimization of the business processes in Regulatory Affairs, by reducing data submission, optimizing the variation regulation, linking data across departments with regards to Falsified Medicines Directive.
ISO IDMP is the enabler to simplify the exchange of data between all stakeholders and re-use the data as previous submitted.
In this course you will receive an update on the latest developments at EMA for the implementation of ISO IDMP. Get prepared for the future, including the explanation about reduction of variations in future.
Understand how IDMP will impact your daily activities. Interaction from early development, during registration, production and marketing the product.
Who is the course for?
The course will benefit all professionals working in departments such as
– Pharmacovigilance / Medical Department (product safety and labeling)
– Production / Serialization
of pharmaceutical company and CROs
Basic knowledge of Regulatory
Session 1: Presentation of ISO IDMP requirements and standard
Legal background, high level overview of the implementation in EU (and US).
Session 2: Introduction and project kick-off meeting for ISO IDMP and Master Data capturing
Comparison between xEVMPD and ISO IDMP.
In depth gap analysis of ISO IDMP standards (data for Substances, Medicinal products, Pharmaceuticalproduct information, unique identification and exchange of units of measurement).
Session 3: Review of data requirements for Iteration 1 ISO IDMP compliance
Session 4: Summary and defining the next steps for ISO IDMP implementation
– Master Data
– Project plan
High level presentation of data requirements for Iteration 2-4, which involves more data from labelling (contra-indications,clinical particulars) and manufacturing (batch information as marketed).
Presentation, including practical session of business cases and questions from audience.
At the end of the training you will be able to understand:
- the data requirements of ISO IDMP – SPOR
- the planning and next steps of ISO IDMP implementation
- the impact of IDMP in other areas of medicines (serialization, shortages, eLeaflet, etc)
Remco Munnik, Regulatory Information Director, Asphalion S.L.
Remco has a Bachelor degree in a study of Management, Economics & Law.
He has over fifteen years’ experience in submission procedures EU/US, electronic submission and regulatory data management. Since 2011 Remco works for Asphalion, an international Regulatory Affairs consultancy, based in Barcelona and Munich. Within Asphalion, Remco is responsible for global eSubmission projects (eCTD, NeeS, RIM,xEVMPD and ISO IDMP). His team is working on CP/DCP/maintenance for EU and FDA(IND/NDA/BLA/maintenance). In addition a dedicated team is focussed on xEVMPD submission and IDMP implementation. In addition he is the chairman of Medicinesfor Europe Telematics working group and in direct contact with EMA and NCAs forthe eSubmission roadmap, eCTD specification, validation criteria, eAF, CESP, Gateway,xEVMPD and ISO IDMP.