NEW SPECIAL ON LINE SEMINAR
CLINICAL SAFETY COURSE
IMPLEMENTATION PERIOD
Date: Wednesday, June 28th, 2023
Time: 10:00-14:00
SPEAKER
Dr GRAEME LADDS
B.Sc (Hons), PhD, MTOPRA, DIA, RQA, IOD, PIPA, MAPS Director
Graeme Ladds has been involved with Pharmacovigiilance for the last 30 years and the last 25 years conducting audits globally in PV and GCP. He has attended over 100 inspections from a variety of Regulatory Authorities and conducted many training courses around the world on a variety of PV related subjects. Director PharSafer Associates Ltd.
PURPOSE
Following the seminar we expect the audience to have:
- Greater understanding of the individual case safety reporting requirements
- Better understanding of the requirements for producing Developmental Safety Update Reports (DSURs)
- Knowing how to look for potential safety signals in clinical trials
- How and what to include for safety information in the Investigator Brochure (IB)
WHO SHOULD ATTEND
This course would be for Clinical personnel understanding more about the safety aspects of clinical trials, Clinical Safety personnel and also Clinical QA for greater understanding of compliance requirements.
course agenda
ICH clinical Trial Safety Reporting
The EU Clinical Trials Directive
Writing Safety Information into the Investigator Brochure
|
Safety Assessments and Signal Detection in Clinical Trials
The DSUR
|
COST OF PARTICIPATION: 350€ |
|
Participants will receive the notes and the Certification of Attendance by e-mail.
Payment will be made by bank transfer or direct deposit to the account of ALPHA BANK: GR66 0140 1230 1230 0232 0001 247 or
PIRAEUS BANK: GR 24 0172 0500 0050 5003 0221 686, up to 3 days before the beginning of the seminar.
Cancellations are accepted without charge up to 5 days prior to the seminar.
Registration - Info
CLINICAL SAFETY COURSE 28/06/23 - 28/06/23Take a few seconds to fill the following information. One of our representatives will call you soon.