Full title: Identification of Medicinal Products (IDMP) Landscape: Global Product Lifecycle Data Management within the Regulatory Environment
When: On-Demand - This is a recording of the live webinar which took place on 16 October 2017
Overview
This presentation will provide case studies representing EU and US environments and the experiences in preparing for IDMP followed-up by with an IDMP regulatory update. Participants in this webinar will be provided with suggestions for implementation based on experience and knowledge of the business drives for global harmonisation.
Learning outcomes
After attending this webinar, participants should be able to :
- Harmonise initiatives and data standards beyond IDMP
- Lessons learnt during IDMP preparations withing the Health Authority Framework
- US and EU comparison in approach
Why should you attend?
By attending this IDMP focused webinar, you will be exposed to experiences across US/EU environments within the Regulatory framework. This webinar will provide an update on related regulatory and industry initiatives to support harmonised implementation strategy beyond immediate compliance for IDMP as it relates to Global Product Lifecycle Data Management (G-PLDM™)
Presenter
Vada A. Perkins is the Managing Principal of IDENTIFICA LLC, an independent global regulatory intelligence and life sciences solutions practice specializing in Global Product Lifecycle Data Management (G-PLDM™).
Before starting IDENTIFICA, Vada began his career as a regulatory reviewer/project manager at the U.S. FDA and retired from uniformed service in 2016 as a Senior Advisor for Regulatory Science/Acting Deputy Associate Director for Regulatory Review Management. Vada worked closely with senior leadership on a broad range of regulatory and policy issues in the development, interpretation, and implementation of guidance, regulations, and international data standards (e.g., ISO IDMP, HL7 SPL, eCTD/RPS, ICSR, UDI) to support the comprehensive review of drugs, biologics, and devices throughout the product lifecycle.
He is a recognized international expert for ISO IDMP as a topic leader for ISO Technical Committee 215/Working Group 6-Health Informatics and serves as lead editor for 5 ISO IDMP related documents. He received his degrees from The Johns Hopkins University and the University of Southern California.
CPD
This course offers 1 CPD hour for successful completion, to learn about why CPD is important visit the Lifelong Learning page.
How do I register?
Prices
| Type |
Member |
Non-member |
| Standard |
£75 + VAT |
£95 + VAT |
Discounted Places
A limited number of discounted places are available at the rates below for those:
Please email meetings@topra.org for a discount code before making your booking.
| Type |
Member |
Non-member |
| Discount |
£35 + VAT* |
£47.50 + VAT* |
* VAT, if applicable, is charged at a rate of 20%.
Terms and conditions
Please read the training terms and conditions before booking this webinar. By booking this webinar, you are agreeing to the terms and conditions.