Sven Deferme appointed training & events manager @ BeCRO
Upcoming trainings:
- Medical Writing, 04-05 June
- Introduction to statistics, 10-11 May
Check the training calendar.
| Why attend? |
This one-day course is intended for investigators and medical writers who need to write study protocols but who lack the experience. The course provides practical guidelines for writing clinical study protocols.
You will get information on the following items:
- Guidelines and legislation (ICH, GCP etc).
- Synopsis
- Aim and use of protocol
- Procedures and best practice in writing study protocols
- Approval and distribution of protocol
- Guidelines on structure and content of a protocol (e.g. tips & tricks, best practice, source documents, etc)
- Protocol associated appendices
No prework is required for this training.
| Program |
9h30 |
- |
10h00 |
Welcome coffee + registration |
10h00 |
- |
12h00 |
Introduction to the protocol |
12h00 |
- |
13h00 |
Lunch |
13h00 |
- |
15h00 |
Guidelines on structure and content of a protocol (treatments, efficacy & safety variables, changes in the conduct of the study, synopsis) |
15h00 |
- |
15h30 |
Coffee break |
15h30 |
- |
17h30 |
Protocol associated appendices |
| Who? |
The workshop will be given by A. Dhoest. After obtaining her PhD at the University of Leuven (Belgium) and her postdoctoral research at the University of Ghent (Belgium), Dr. Dhoest has been working both in-house and freelance as a scientific writer for the pharmaceutical industry.
PharmaXL started in 2004 as a training center in order to fill the need for 'brain updates' in the pharmaceutical industry. The different workshops organized by PharmaXL have been attended by many medical and pharmaceutical professionals and students. This training is organized in cooperation with ECCRT.
| Where and when? |
This course will take place on May 15 and November 13, 2012 in the training facilities of ECCRT in Brussels, Belgium (Keizer Karellaan 576, 1082 Brussels).
| How much? |
students* |
€137.5 (VAT incl) |
academics/industry |
€550 (VAT incl) |
* Students pay only 25% of the total fee. Please provide us with a document signed by the dean of your faculty as proof.
Please ask for our special group rates! If this training is combined with the training 'Pitfalls of clinical study report writing', the course fee is €950!
This subscription fee covers for the registration, coffee breaks, lunches and course material. The subscription fee does not cover for the hotel and/or travel expenses.
| How to register? |
People who want to register for this course on protocol writing, please fill out the registration form.