Pre-Conference Short Courses
Short Courses are designed to enhance your knowledge in both broad and specific areas to improve your day-to-day job function. You can add Short Course offerings for an additional fee to your DIA Europe 2027 registration or register for them as standalone events.
How to Navigate the Parallel HTA and EMA Processes in the EU
This course will discuss regulatory preparedness for the JCA process, explain the interface between regulators and EU HTA Coordination Group and which information is shared by the two.
At the end of this Pre-Conference Short Course, participants will be abe to:
- Understand the JCA process and how it links to the marketing authorisation process
- Understand the role of prospective evidence planning/Joint Scientific consultation
- Preparing and aligning internally
This Course is aimed at Regulatory strategy leads, Regulatory authority members, Clinical development professionals as well as CROs and Consultants involved in EMA's approval processes.
View Course Programme Learn MoreUnderstanding ICH E6(R3) Annex 2 for Evolving Clinical Trial Designs
This course offers practical guidance on applying Annex 2 across the clinical trial lifecycle, including expectations for investigator and sponsor oversight, safety data collection in pragmatic, decentralised and technology-enabled settings, and the assessment of RWD fitness-for-purpose and access pathways.
At the end of this Pre-Conference Short Course, participants will be abe to:
- Understand the expectations outlined in Annex 2
- Apply decentralised, pragmatic, RWD-related and technology-enabled approaches
This Course is aimed at professionals working in Clinical operations, Clinical research Clinical safety and pharmacovigilance as well as Regulatory affairs and Quality assurance and quality control.
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