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PTF22 – Managing the Clinical Study Protocol Writing Process
Who it is for
This workshop is aimed at company staff and freelance medical writers who are interested in learning how they can make an effective contribution to the protocol writing process by taking a leading role. Previous participation in the workshop on The Clinical Study Protocol is recommended.
What it covers
The workshop will cover the role of the medical writer in leading the protocol writing process as a member of a multifunctional team.
Best practices (do’s and don’ts) will be covered showing how a medical writer can best lead the team through the different steps in the process (from the kick-off meeting with the study team to the finalisation of the document)... Useful tools and practical approaches that can make the process easier will be presented.
Abe F. Shevack MA, ELS is a Biologist with many years of experience in basic research in both academia and industry. He is also a certified Editor in the Life Sciences. For over 20 years as a senior scientific medical writer at Schering and
Bayer, Abe wrote numerous regulatory documents including clinical study protocols, investigator’s brochures, study reports, and CTD documents for global regulatory submissions. He has worked in a wide range of therapeutic indications and has
participated in successful global marketing authorizations for new drugs in leukemia, non-Hodgkin’s lymphoma, hepatic cell carcinoma, macular degeneration, and men’s health. Since 2016, Abe has been the owner of Associated Medical Writer Services where he writes and consults for clients in pharma and biotech. He has been a member of EMWA since 1996 and is a past-President (2017-2018) and workshop leader. He is currently the chair of the EMWA Ambassador’s Programme.
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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.