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DDF17a – Ethical Issues in Clinical Trials
Who it is for
This workshop is intended for medical writers (and others) who are interested in clinical trials and would like to know more about the evolution of ethical principles associated with human subject participation.
What it covers
Global ethical aspects that are taken into consideration for studies will be reviewed. In addition, case examples of situational clinical trial and medical ethics will be provided for interactive discussion.
This workshop will consist of a combination of presentations on relevant ethical issues, with respect to clinical trials, and group discussions on challenging ethical considerations of some “real-world” case studies. The presentations will focus on the importance of ethics in GCP, the informed consent process, and the challenges that may arise in developing countries. Practical experience will be shared with the participants.
Art has a background in neurophysiology and behavioural medicine. As an independent consultant, he specialises in regulatory strategy, Data Safety Monitoring Board management, medical writing, and bioethics. Art has held senior posts at a
number of companies including Schering-Plough/Merck, Hoffmann-LaRoche, TFS,
and Quintiles, and headed departments responsible for medical writing, publications, project management, and regulatory affairs. He also served as a Senior Research
Fellow with the Centre for Innovation in Regulatory Sciences (CIRS). Art has extensive teaching experience and has presented to professional organisations (e.g. EMWA, AMWA, DIA), and corporate and academic audiences, worldwide. He spent 2 years heading Clinical Operations for an eDC ‘dot.com’ company, and has been active in CDISC since its inception. He served as Chair of the Global Ethics and Regulatory Initiative (GERI) of the Alliance for Clinical Research Excellence and
Safety (ACRES). He is a Founding Member of the Global Alliance of Publication
Professionals (GAPP), a Past President of AMWA, and a Fellow of both AMWA and EMWA. Art served in a Senior Advisory capacity on the Budapest Working Group in developing the CORE Reference. He has a particular interest in bioethics in the
context of clinical studies, is an advisor to an IRB, and serves on a number of task forces focusing on improving the drug development process while protecting the rights and safety of clinical study participants.
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Registration fee first
The conference registration fee (€50) must be in your basket before any session can be added. It is one off and covers the opening session and the plenary.
Terms and conditions
Changes to registration
Changes may be made to workshop or seminar choices after booking (that is, a cancellation of one workshop or seminar choice and replacement by another), for an administrative fee of €27, plus any difference in price between the choice of workshops or seminars. Workshops, seminars and lunchtime sponsored sessions may be added to your original registration (subject to availability) at any time, without an administrative fee by contacting info@emwa.org. All changes are subject to availability.
Cancellation of attendance
If you wish to cancel your attendance at the conference, a refund, minus an administration fee of €162, will be made provided your cancellation is made in writing to EMWA head office before 20 October 2026. No refunds will be made after this date.
Payments
Invoices must be settled by bank transfer in Euro, or paid by card through Stripe. All fees are payable in advance. Full payment is due by 30 October 2026. If payment has not been received, EMWA reserves the right to request payment and cancel registration.