IDMP Compliance Challenge: Hit the phased approach deadlines

13 - 15 April 2016

This marcus evans conference has focused on IDMP compliance preparations benchmarking and knowledge-sharing for the phased approach deadlines, and has gathered corporate professionals from key stakeholder departments progressing on IDMP projects with already some lessons learnt and practices to share for those who are less advanced in the journey. 

Identification of Medicinal Products (IDMP) is one the biggest regulatory challenges for all pharma companies in Europe. The latest regulatory update has defined IDMP compliance as a phased approach with a preparation phase between now and the end of June 2016, followed by a transition phase. The 1st iteration will be focusing on product and substance information, with further standards to come.

Despite the fact the implementation guidelines have not been published yet, decisions about the compliance preparations need to be already made today as this legislation has major implications for all companies active in the industry and this means a lot of work to be done in an a very short timeframe.

Keynote Presentation

"IDMP: Are you ready for the new Compliance Generation?"

Renato Rjavec (AMPLEXOR's Director of Products, Life Sciences) and Sinisa Belina (AMPLEXOR's Senior Life Sciences Consultant) will discuss:

  • Status and update on ISO IDMP
  • IDMP Impact assessment and Business preparation
  • How to overcome IDMP Challenges
  • Key differences between XEVMPD and ISO IDMP

Location

Marriott Hotel

Hamburger Allee 2

60486 Frankfurt am Main

Germany