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On the 27th October 2022, the GetReal Institute held a webinar to present the MHRA and NICE guidelines and framework, and to discuss the impact of these beyond the UK.
The MHRA is producing a series of guidelines to provide general points to consider for sponsors planning to conduct clinical research using real world data to support regulatory decision making. NICE developed their Real World Evidence Framework in June 2022 describing best practices for the planning, conduct and reporting of real world evidence studies, to improve the quality of real world evidence informing NICE guidance.
In this webinar, we discuss the impact of the MHRA RWD guidelines and NICE RWE Framework internationally, including the shaping and alignment with other Regulatory and HTA agencies, and whether the UK is well positioned to take a leading role in the advancement of real world data and evidence internationally.
Speakers:
* David Brown, Head of Statistics, MHRA
* Seamus Kent, Former Senior Adviser – Data & Analytics, NICE
* Pall Jonsson, Programme Director – Data & RWE, NICE
* Rachael Williams, Observational Research Team Leader, MHRA
Moderator: Shahid Hanif, Managing Director, GetReal Institute
