In September 2023, the European Medicines Agency (EMA) will reinstate their Policy 0070 requirement to publish all clinical studies submitted to the EMA for regulatory approval. After almost five years of being offline (other than for COVID-19 submissions), the process and new standards that go along with Policy 0070 will likely be new to many sponsors looking to authorize their product in the EU.
This webinar will focus on three parts. Firstly, an expert will share the updates and changes to the policy and how they will impact sponsors submitting for regulatory approval. Secondly, presenters will lead a discussion on what they have learned during the suspension of Policy 0070 and how we can use this knowledge to help improve new submissions. And lastly, presenters will explain how experience with other regulatory submissions can be leveraged to the newly reinstated process of submitting clinical data to Policy 0070.
Registration Fees
Free
Learning Objectives
- Learn what has changed in the process of submission to EMA Policy 0070
- Get some tips & tricks on how to identify and redact CCI prior to submission
- Learn about some of the feedback that has been given from EMA and other regulators to avoid common mistakes
Who Should Attend?
- Data Transparency & disclosure staff
- Clinical Research Organization staff (medical writers, project managers, transparency teams)
- Individuals working in Regulatory Affairs
