DSUR

ADVANCED CERTIFIED PROGRAM IN Development Safety Update Reports (DSUR)

The Development Safety Update Report (DSUR) is intended to be the common standard for annual clinical trial safety reporting in the ICH regions (Europe, Japan and the US) and became a requirement in the EEA in September 2011. The main aim of a DSUR is to present an annual review of the safety profile of investigational medicinal products and to evaluate all relevant safety information collected during the reporting period. This new course will give delegates a thorough grounding in the background and practical delivery of DSURs, provided by experienced speakers from the pharmaceutical industry.

The focus of the lectures will be mainly on the following topics:

  • The content of DSURs as defined in ICH E2F
  • The complexities of planning, managing and writing a DSUR
  • Regulatory aspects of DSURs: Guidance within EU/C 172/01
  • Presentation of safety data
  • Key concepts of the DSUR, RSI, IB and DCSI
  • Production of a model DSUR

Upon successful completion of this course, Trainees should be able to:

  • Understand the detailed requirements for the content of DSURs
  • Grasp the regulatory aspects of DSURs
  • Demonstrate an understanding of the best ways to obtain, analyse and present safety data in a DSUR

ELIGIBILITY:

Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following:

Applicants are recommended to have one of the following life Science degrees: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics)   and all professionals working with Pharmaceutical companies, CROs and Hospital.      

SELECTION PROCEDURE:

To Maintain High Academic Standard, Gratisol Labs Gives Due Importance To The Quality Of Students Enrolled. To Ensure This, The Selection Of Individual Student Will Undergo The Following Procedure:

Personal Interview 

Screening And Selection Of Students

CERTIFICATION:

Certificate will be provided for this Course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by Gratisol Labs.

A fast track weekend course will also be conducted for employees & aspirants of Clinical Research Industry.  For more information, please contact Gratisol Labs at This email address is being protected from spambots. You need JavaScript enabled to view it. .

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Contact

GRATISOL LABS – HYDERABAD
KVR Enclave, 2nd Floor, 207, Gurudwara Lane,
Beside Satyam Theater, Above ICICI Bank,
Ameerpet, Hyderabad– 500016,
Cell: +91 9705790302 / +91 8885198390
E-mail: training@gratisol.com