IDMP - what you need to do NOW

Detailed programme

09:00 - 17:00 seminar
You may dial in 30 min. before the session

09:00

Introduction round using the ZOOM whiteboard

• Reconciling participants' expectations with the programme

09:15

Georg Neuwirther

IDMP introduction, rationale and implementation status

• ISO IDMP: rationale and implementation status
• ISO IDMP essentials - data structure and IDs: Pharmaceutical Product Identifier (PhPID), Medicinal Product Identifier (MPID), Packaged Medicinal Product Identifier (PCID)
• ISO IDMP and its potential use in telematics projects (eAF, TOM)

10:25

Is the IDMP rationale and implementation clear? Short break to review and formulate additional questions

10:40

Georg Neuwirther

IDMP and SPOR: How are they related?

• SPOR requirements and status

11:00 Coffee break

11:15

Remco Munnik

IDMP EU Implementation Guide - version 2

• Data elements as requested for iteration 1 - review of the mandatory data elements, including an evaluation of the source and data management of these fields
• Which medicinal product information will be submitted in the new format?
• Pharmaceutical and medicinal products
• Marketing authorisation information
• Therapeutic (product) indication
• Ingredients
• Packaged Medicinal Product Identifier (PCID)
• Technical specifications on structure and format
• Migration from XEVMPD to PMS - status
• Version 2 - current status and forecast

12:00

IDMP Implementation Guide: Is everything clear? Short break to review and formulate additional questions

12:15

Remco Munnik

SPOR step 1/step 2 concept

12:45 Lunch break

13:30

Remco Munnik, Georg Neuwirther

Interactive session: Bring your products and share them virtually

• Describing medicinal products in IDMP, using examples submitted by participants beforehand

14:45 Coffee break

15:00

Remco Munnik

Collecting, cleaning and structuring data: the most urgent things to do

• Regulatory/PV/production data

15:30

Wrapping up the urgent things to do. Short break to review and formulate additional questions

15:45

Remco Munnik

Building project teams to process IDMP/SPOR implementation

• Responsibilities, duties and project leadership

16:10 Coffee break

16:15

Remco Munnik, Georg Neuwirther

The next steps

• ePI - structured electronic product information: A digitalisation project potentially utilising IDMP and SPOR

17:00 End of seminar

Detailed programme

09:00 - 17:00 seminar
You may dial in 30 min. before the session

09:00

Introduction round using the ZOOM whiteboard

• Reconciling participants' expectations with the programme

09:15

Georg Neuwirther

IDMP introduction, rationale and implementation status

• ISO IDMP: rationale and implementation status
• ISO IDMP essentials - data structure and IDs: Pharmaceutical Product Identifier (PhPID), Medicinal Product Identifier (MPID), Packaged Medicinal Product Identifier (PCID)
• ISO IDMP and its potential use in telematics projects (eAF, TOM)

...