Webinar: Research, Ethics and Regulatory Affairs

Webinar: Research, Ethics and Regulatory Affairs
This session will be an interactive discussion of emerging ethical issues in research within a changing regulatory landscape. Ethical considerations affecting the design of clinical trials of investigational medicines and medical devices, ranging from the persistent role of placebo controls, the rise of real-world data collection and adaptive regulatory pathways, to the need for community engagement or public and patient involvement in research and methods for consent in different cultural contexts. As well as learning about hot topics, you can have your questions answered by a panel of experts.

Date:  22 April 2024
Time:
 2pm - 3.30pm (GMT)

Course overview

Over the course of this webinar, our expert speakers Professor Sarah Edwards and Dr. Rakhshi Memon will guide you through the following aspects:

Learning outcomes:

·  To appreciate role of ethics in regulatory affairs

·  To become familiar with ethical issues in a changing regulatory environment

·  To understand how to navigate the process of review by ethics committees

·  To engage with research to advance the discipline of research ethics 

The webinar will take place over the course of 90 minutes, with a one-hour presentation, with 20 minutes for a Q&A session with our webinar presenters, followed by a 10-minute assessment. The assessment will take place in our virtual learning environment and you will be set details after the session has finished.


Inside the ethics committee

Agenda:

·  2pm – Hot topics in ethics for a changing regulatory environment

·  2.30pm – Engaging with ethics committees

·  3pm - Q&A

·  3.30pm -  Close  

Audience:

  • Delegates from the regulatory affairs industry who wish to obtain a better insight into the current discussions around ethics in regulatory affairs
  • MSc and PhD students who are preparing for their dissertations
  • Regulatory professionals who wish to gain a comprehensive understanding of the subject.

    Speakers:


    Professor Sarah Edwards

  • Sarah JL Edwards is the Professor of Bioethics at UCL having trained in Psychology, in Philosophy, and in Medical Ethics and Law, concentrating her research career on research ethics in health. She has a track record of interdisciplinary research publications and policy impact. She currently leads several research projects on use of real-world evidence in regulatory decision making, on using social sciences alongside clinical trials eg to improve recruitment rates, and on cultural challenges to harmonisation of regulatory rules. She is currently collaborating with members of international bodies such as CIOMS and WHO as part of these projects. She also leads the new professional education programme in science, technology and engineering policy and co-leads new health route through the Masters in Public Administration at UCL having taught medical ethics and law to medical students, translational clinical science and regulatory affairs for postgraduates, and research ethics and governance to clinical researchers and managers.  

        Dr Rakhshi Memon

    Rakhshi Memon has a PhD in bioethics from University College London, UK. Her main area of interest is in concepts such as equipoise and consent with a focus on culture and research ethics. She has extensive experience working with research teams in LMICs such as Afghanistan, Bangladesh, India, Nigeria, UAE and Turkey. In the UK, she has facilitated numerous workshops on community engagement and research projects with British South Asian and Black African and Caribbean populations. Her background is in the NHS specialising in improvement sciences with a particular focus on change management and human dimensions of change.  


    Learning outcomes:
  • To appreciate research ethics as the study of moral values in research
  • To identify moral values at stake in research
  • To outline potentially conflicting moral values
  • To demystify review by research ethics committees 
  • To assess the cultural context of systems of research ethics governance 
  •  

     
    Non-member: £114 (Including VAT)
    Member: 
    £84 (Including VAT)

     

    When
    22/04/2024 14:00 - 15:30
    Where
    ONLINE
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