Veranstaltungen

BioM Workshop: Medical Writing in clinical trials

Medical writing in clinical trials – what, who, why and how? This workshop adresses the tasks, the documents and the timelines involved. Best practices will be covered showing how clinical researchers can best lead the team through the different steps in the document preparation process.

---The workshop is fully booked ---


Time and Place

Thursday, July 5, 2018; 9:00 am – 4:30 pm
BioM Biotech Cluster Development GmbH
Am Klopferspitz 19 a (IZB West II, 3. OG)
82152 Martinsried

Content
Medical writing in clinical trials – what, who, why and how? This workshop will address these questions and covers the tasks, the documents and the timelines involved in the medical writing process in clinical trials. The role of medical writers and how they interact and support the multifunctional clinical research team will be discussed.

Best practices (do’s and don’ts) will be covered showing how clinical researchers can best lead the team through the different steps in the document preparation 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.

Main Topics

  • Introduction to the Role of Medical Writers in Clinical Trials and Drug Development Process
  • Managing the Clinical Study Protocol Writing Process
  • Protocol writing Management
  • The Clinical Study Report (CSR) Development Process
  • Transparency and Disclosure (EMA Policy 0070 and the GDPR)

Goal
The objective of these of presentations and workshops is to describe and explain the medical writing needs and tasks within a clinical trial and how clinical researchers can manage and oversee these tasks effectively.

Target group
People from biotech/pharma companies such as project managers and clinical trial managers who set-up, lead and run clinical trials.

Speakers
Abraham F Shevack MA, principal owner of Associated Medical Writing Services (AMS), past-president of the European Medical Writers Association (EMWA)
Raquel Billiones, PhD, Head of the Medical and Regulatory Writing group and country manager for Switzerland at Clinipace Worldwide, active member of the European Medical Writers Association (EMWA)

Flyer
The detailed agenda for the BioM Workshop "Medical Writing in clinical trials" can be downloaded (pdf).

Organisation
Gabriele Klingner 
BioM Biotech Cluster Development GmbH
Email: klingner@bio-m.org 
Phone: +49 (0) 89-899679-15

Registration
Registration fee: 150 Euro (+ VAT) for Academia, 250 Euro (+ VAT) for Industry