Canadian, UK and US regulatory horizons: navigating the approval and compliance landscape for psychedelic-assisted treatment

18 Nov 2024 1400 - 1500 GMT

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A webinar presented by the IBA Healthcare and Life Sciences Law Committee and supported by the European Regional Forum, the IBA Product Law and Advertising Committee and the IBA International Commerce and Distribution Committee.

Topics will include:

  • The FDA, MHRA and Health Canada's role: Explore the rigorous approval mechanisms for psychedelic substances by these agencies, highlighting the nuances involved in bringing such treatments to market.
  • Rescheduling psychedelics: Understand the timing and processes behind the US DEA and Canadian RCMP's potential rescheduling of psychedelics, in the event of regulatory endorsement.
  • Risk Evaluation and Mitigation Strategies (REMS): Delve into REMS and its expected components, like healthcare training and informed consent protocols, that could shape the future of psychedelic-assisted treatment.
  • Compliance and international impact: Review key compliance factors and consider the broader repercussions on international treaties if psychedelics gain regulatory acceptance.
  • Global clinical trials: Discuss intriguing examples of psychedelic-assisted treatment trials around the world, offering insights into the therapeutic promise and challenges faced by researchers.

Fees

IBA member

Free

Non member

Free

Certificate of Attendance

Certificates of attendance for this webinar will be provided to all delegates who have registered in advance and attended the live broadcast for a minimum of 30 minutes based on verified sign-in and sign-out times. The certificate will be sent to the email address provided at the time of registration. Certificates can only be issued to the name provided at the time of registration. If you have any queries relating to your Certificate of Attendance, please email webinars@int-bar.org

Co-Moderator
Peter Wagner

Co-Moderator
Jordan & Wagner Rechtsanwaltsgesellschaft mbH, Stuttgart, Germany; Webinar Officer, International Commerce and Distribution Committee

Alan Adcock

Co-Moderator
Tilleke & Gibbins, Bangkok, Thailand; Asia Pacific Regional Forum Liaison Officer, Healthcare and Life Sciences Law Committee

Confirmed speakers
Sabrina Ramkellawan

Speaker
AxialBridge, Toronto, Ontario, Canada

Kimberly Chew

Speaker
Husch Blackwell, Oakland, California, USA

Jaspreet Grewal

Speaker
AxialBridge, Calgary, Alberta, Canada

Jonathan Deverill

Speaker
DAC Beachcroft, London, England