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Medical Monitor’s Perspective on a Protocol
Who it is for
Open to EMWA members registered for the EMWA Autumn Conference 2026.
What it covers
Clinical study protocols can look polished on paper. However, once sites begin using them, they can still create confusion, deviations, safety risks, and operational burden. In this practical session, Livia shares insights from her time as a medical monitor before becoming a regulatory writer. The talk will cover common protocol topics, including background, study design, eligibility criteria, CTCAE grading, discontinuation rules, efficacy assessments, safety review, and committee interactions. Attendees will leave with a clearer understanding of what can happen after a protocol is approved and sites begin putting it into practice.
Livia Hlavackova, MD, PhD, is a Principal Regulatory Writer at Bioscript Group with a Diploma in Pharmaceutical Medicine and more than 17 years of experience in clinical research and regulatory writing. Her work spans pharmaceutical and medical device development, with expertise in clinical study protocols, clinical study reports, investigator brochures, informed consent forms, and other regulatory documents. Prior to specialising in regulatory writing, she worked as a medical coder and medical monitor within a CRO environment. She also has experience in public speaking, including delivering a TEDx presentation and a conference presentation on medical device clinical research at an international industry meeting in Munich.
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Booking is for EMWA members
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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.