On Friday 22 September 2017, DARQA GCP commission invites you to participate in the GCP/ GVP event on

“Safety Information from a GCP Perspective”

The subject will include the safety information in different phases of products life cycle from clinical trials to post marketing phase.

The day will start off with core concepts in pharmacovigilance, proceeding to look at reference safety information which GCP professional come across in the clinical trial setting in the light of the new EU Clinical Trial Regulations and at Investigator sites during day to day monitoring. The post marketing aspect of reference safety information will also be covered in the following sessions.

Program

9:30                             Arrival and Coffee

9.45 – 10.30                Pharmacoviligance Auditing Core Concepts

                                     Speaker: Marielle Keulen, Senior Consultant Xendo

10.30 -11.15                Reference Safety Information in Clinical Trials

                                     Speaker: Deepti Naik, QA Auditor PRA Health Sciences

11.15 – 11.45              Break

11.45 – 12.30              Reference safety information in de post-marketing setting

                                     Speaker: Marielle Keulen, Senior Consultant Xendo

12.30                           Lunch

13.45 -14.30                Safety Information at Investigator Sites

                                     Speaker: Han van Hirtum, CRA PRA Health Sciences

14.30 – 15.15              Reference Safety Information from a QA perspective – Observations and Trends

                                    Speaker: Laurentiu Chitimia, Associate Director Pharmacovigilance QA Astellas

15:15 – 15.30              Q & A

15.30                           Snacks

17:00                           End