webinar
Ask the Experts: EU CTR/CTIS: Adoption and Early Experience
The EU Clinical Trials Regulation no. 536/2014 became effective on 31 January 2022 and the first approved trials are now…
webinar
How to use Scientific Advice to enhance your product development strategy
Scientific Advice (SA) is one of the important interactions a developer can have with a regulatory agency (national or European…
blog
The implementation of the Clinical Trial Regulation (Regulation (EU) No 536/2014): where do we stand?
While the Regulation (EU) No 536/2014 was adopted back in 2014, its application in the European Union depends on the…
publication
Driving the Healthcare Regulatory System Into the Future
This is a summary report on the panel discussion at the TOPRA Symposium 2020. The panel discussed how the EMA…
blog
Expectations from Regulatory Agencies on Nitrosamine Impurities
On Friday, 27th March 2020, the European medicines regulatory network extended the deadline to complete an initial risk evaluation for…
Case study
An Integrated Regulatory and Market Access Solution for a Successful MAA
A US-based biotech looked for a trusted regulatory partner to: 1) Build and execute an EU regulatory strategy and roadmap…
webinar
Unlocking the EMA Meetings: the Process and How to Prepare Adequately
Clear strategy, compelling argument and well-rehearsed preparation are all key to having a successful EMA meeting, no matter if it…
webinar
To Go or Not To Go Into Parallel Consultation
Are you wondering about the feasibility of parallel consultation, what sponsors should be aware of, as well as the opportunities…
