Training information

Category Regulatory and Compliance

Impact of ISO IDMP/SPOR on daily regulatory operation

Outlook of the future environment of data collection, submission, validation and re-use

Impact of ISO IDMP/SPOR on daily regulatory operation

Date: 16-17 October 2017 | 9.00-18.00

Location: Hotel Melià - Milan

Language: English

Lecturer/s: Remco Munnik

*Registration fee: € 1460,00 + IVA

*Early bird: 02/10/2017


Registration

Brochure

Introduction

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

– Regulatory

– Pharmacovigilance / Medical Department (product safety and labeling)

– Production / Serialization

of pharmaceutical company and CROs

Participant experience

Basic knowledge of Regulatory

Programme

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

– Substance
– Product
– 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).

Type of training

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)

Lecturer’s Bio

Remco MunnikRegulatory 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.