PSUR

ADVANCED CERTIFIED PROGRAM IN Periodic Safety Update Reports (PSUR) 

The Periodic Safety Update Report (PSUR) is a widely accepted standard for post-marketing safety reporting of aggregate data. This course will break the PSUR down into its building blocks and examine them in detail, including a comparison of ICH, Volume 9a and other “local” PSUR requirements. Key PSUR concepts will also be explored, including International Birth Dates (IBDs), harmonizing reporting times and intervals, restarting the clock, time interval between data lock-point and the submission, reference safety Information. Summary bridging reports and addendum reports will also be covered. This course is offered at a beginner level and is intended for health care professionals working in drug safety/pharmacovigilance.

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

  • History and rationale for PSURs
  • Changes to PSURs under new EU PV Legislation - compare and contrast with current requirements
  • Format and content of a PSUR
  • Planning and writing a PSUR
  • Reference Safety Information for PSURs
  • Calculation of exposure data for PSURs
  • How to gather and evaluate data for PSURs
  • Regulatory aspects of PSURs

On successful completion of this course Trainees should be able to:

  • Analyze the purpose and scope of PSURs and Marketing Authorization holder responsibilities
  • Assemble and appraise a PSUR from diverse information sources and explain the management steps in report submission
  • Critically evaluate data within PSURs for purposes of signal detection

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) 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