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AlphaLife Sciences – AI-Assisted Medical Writing That Holds Up to Review
Who it is for
This webinar is designed for medical writers, regulatory writers and medical writing leads in pharma, biotech and CROs who prepare clinical and submission documents.
If you have tried AI on a draft and found that it read well but left you with more to verify, or if you have not tried it yet and want to know how it might change your day-to-day work, this session is for you. No experience with AI tools is needed. Leads who set up documents and manage review rounds, and anyone who has to sign off on an AI-assisted draft, will find it directly relevant.
What it covers
How soon a document reaches finalisation often depends on review: how much you and your reviewers have to resolve, and how aligned the team are ahead of document sign-off.
Review often takes longer than drafting. Using AI to generate a first draft much faster than before is a real gain, but it can add to the review burden: every sentence must be checked against its source. The aim is to ease that burden within your existing SOPs.
In this session, we follow one clinical document from set-up to finalisation. At each stage you will see where AI can help and where the writer decides: a template, source list and key messages proposed for the lead to confirm; a draft showing the source behind each statement, gaps flagged rather than filled; specialist AI reviewers that can check the draft before your colleagues do, with evidence for each finding and a writer deciding how to respond; all comments in one list, conflicts flagged for you to resolve; and, when final tables arrive, targeted updates shown as tracked changes for you to accept or defer. Sign-off stays in your document management system, with a record of who changed what.
We then explore six responsibilities that remain yours, from setting the key messages to presenting unwelcome data honestly and resolving disagreements between reviewers; the skills to build now; what regulators expect; and five things to try on Monday. AI can help with the sentences. The writer decides what the document presents.
AI Product Manager Head, AlphaLife Sciences
Viktor Fási is AI Product Manager Head at AlphaLife Sciences, where he leads product strategy for AuroraPrime, an AI-native platform for regulatory and medical document authoring. His work sits where regulated enterprise delivery meets applied AI: let the model draft, then lock the output into something deterministic and auditable that a human signs off. Viktor spent more than eight years at Veeva Systems leading commercial practices and delivering global rollouts for top pharmaceutical companies, several spanning more than 100 countries. As Head of Product at Antavo, he built the product management team from scratch through a Series A. After that, at Cursor Insight, he led product, delivery, data science and engineering teams on biometrics and video AI, with projects ranging from Alzheimer's predictors to validation work for the ITER fusion reactor.
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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.