Looking for companies to speak to their pain points and experience in handling the release of the publication & experience/ strategy with regards to implementation

Some people never thought it would go live- 6mths after publication
Companies in denial phase- not need to deal with it now as there is a 3 year transition period
Some companies keen to start using it straight away- make the most of harmonisation for multiple member states using one submission
Others are waiting and worrying about it later – depending on who you speak to
Regulatory authorities have had time to prepare for this
The ethics committees found it a challenge – more than one EC per country so difficult to have a unified review of the dossier
Released in 2014- took 7 years to actually get from release to go live-Lots of enthusiasm to start with
Ultimate delay was due to the IT system and portal access – huge database to set up to manage applicants – multiple members states, ethics committees. Huge task
UK- have their own process- combined review- mHRA and EMA – similar concept. UK was paramount in putting their CTR together. One submission covers EC and Reg authority- one harmonised assessments and one approval.

Tom DenormeDirector, Regional Submissions Lead Head, GCTO EMEA at MSD, BelgiumSpeaker

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See Tom at EU Clinical Trials Regulation

Tom Denorme
Director, Regional Submissions Lead Head, GCTO EMEA at MSD, Belgium
Speaker