REGULATORY WRITING

19th-20th April 2012, Warsaw

This two-day training workshop covers the basics of writing documents for regulatory use in the pharmaceutical industry. It has been developed both for dedicated medical writers and for any clinical research professionals who write documents associated with clinical trials, such as protocols, clinical study reports (CSRs), and Investigator Brochures (IBs).

Są to dwudniowe warsztaty poświęcone przygotowywaniu dokumentacji dotyczącej badań klinicznych dla krajowych i międzynarodowych agencji nadzorujących obrót lekami i środkami medycznymi (URPL, EMEA, FDA) oraz do komisji bioetycznych. Szkolenie adresowane przede wszystkim do przemysłu farmaceutycznego, przeznaczone jest dla osób, których zadaniem jest tworzenie lub recenzowanie dokumentów takich jak: protokół badania, raport końcowy badania (Clinical Study Report) oraz broszura badacza (Investigator Brochure).

(agenda) (lokalizacja)

Day 1

09.00–12.30	Introduction Putting the CSR in Context The CTD regulatory pyramid The summary of the CSR Presenting The Methods Including the protocol Including the statistical analysis plan Dealing with protocol amendments Describing the Study Population Presenting Efficacy Data and the Pharmacokinetic Data
12.30–13.30	Lunch
13.30–17.00	Presenting Safety Data Adverse events Laboratory data Other safety data Writing Narratives Finishing Off the CSR Discussion End-of-Text Tables and Figures Appendices Compiling the CSR Trouble Shooting
17.00	Close (approx)

A brief break will also be included mid morning and mid afternoon

Day 2

09.00–12.30	Protocol Writing Getting started - rules and regulations Protocol development process - key tasks and team members CRF/protocol relationship Study design Protocol summary Format and layout of protocol Appendices Protocol amendments How to review a protocol
12.30-13.30	Lunch
13.30–15.00	Investigator Brochures What should be included and why Format and layout of an IB Review and QC How to review a document and provide feedback What QC does and doesn't include
15.00	Close (approx)