Advanced Certified Pharmacovigilance Drug Safety Associate Training Programme - Hyderabad

Organization at a Glance:
Global Institute of Advanced Pharmaceutical & Health Sciences (GIPHS) is a highly specialized consulting firm focused solely on serving the Drug Safety, Regulatory Affairs, Quality Assurance & Risk Management needs of our clients. We deliver surpassingly qualified consultants to companies in the pharmaceutical and biotechnology industries. The Certificate in Drug Safety Associate program at GIPHS provides complete hands on Training in drug safety and Pharmacovigilance on Oracle Argus Safety Database 7.0.3 version including regulatory requirements, adverse event reporting, signal detection and risk management. This program will focus on the regulatory issues across global government agencies that improve safety. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence, and regulatory compliance. This program will provide learners with the regulatory references, processes, best practices, and analysis & investigation techniques. Practical Training will be also provided on industry-based tools on topics such as data entry, case processing, MedDRA & WHODD coding and SAE narrative writing.
The focus of the lectures will be mainly on the following topics:
•History and over view of pharmacovigilance
•Introduction and responsibilities: USFDA, EMA and CDSCO
•Pharmacovigilance in India
•Clinical Development process
•Different phases of clinical Trials
•Adverse events and its types
•Drug Safety in clinical trials and post marketed drugs
•Different sources of Adverse events reporting
•Different types of AE reporting Forms
•Expedited reporting and its timelines
•Different departments working on Pharmacovigilance
•Roles and responsibilities of case receipt unit
•Roles and responsibilities of Triage unit
•Four factors for the reportable case
•Seriousness criteria of adverse event
•Expectedness or Listedness of adverse event
•Causality assessment of the adverse event
•Introduction to safety databases and different types
•Importance and procedure of duplicate check
•Case bookin or initiation
•Introduction to MedDRA and WHODD
•Narrative writing
•Case quality check, Medical review and its submission.
•The Qualified Person for Pharmacovigilance (QPPV) in the European Economic Area
•PSUR and its submission timelines
Mode of training- Instructor Led Class room Training
Note: Industry Experts from Novartis, Parexel, TechMahindra, Infosys, HCL, MakroCare, Andronovo Labs, Aurobindo Pharma, Natco Pharma, Dr Reddys will deliver the classes.
Tenure: 2 months


Eligibility
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) / 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 Leading MNC IT companies.
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 Global Institute of Advance Pharmaceutical Sciences & Health Sciences.
For more information, please contact at training@giphs.com
For More Details: Please Contact
Dr.Anita Singh
Training Coordinator
Global Institute of Advanced Pharmaceutical & Health Sciences.
Academy of Clinical Research
KVR Enclave, 2nd Floor, Ameerpet, Hyderabad
Mob No:+91 8019163577
Email: training@giphs.com
Web: www.giphs.com