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Certificate in Drug Safety Aggregate Reporting

IGMPI provides an opportunity for all the working professionals to enhance their knowledge and skills in the field of Safety Aggregate Reporting. Aggregate reporting includes the collection of safety data information for a drug throughout an expanded period of time, rather than single-case reporting which, by definition, includes just individual Adverse Event reports. The work profile of a Drug Safety Aggregate Associate is to assess the safety of the drugs once they are into their Phase IV i.e., Post marketing surveillance. They assess the adverse events and report whether these event are related to that medicinal product or not. These reports help the regulators in assessing the risk Benefit Profile of drug over a period of time.

This programme is devised with an all-intensive and thorough research to impart complete conceptual knowledge of Pharmacovigilance safety reports, their significance, preparation and their types. Professionals working in Pharmacovigilance and Clinical Research industries will benefit from this programme.

Programme Modules

Module 1: Basics of Pharmacovigilance
Module 2: Aggregate Safety Reports
Module 3: Developmental Safety Update Report (DSURs)
Module 4: Periodic Safety Update Reports (PSURs)
Module 5: Periodic Benefit- Risk Evaluation Reports (PBRERs)
Module 6: Periodic Adverse Drug Experience Reports (PADERs)
Module 7: Industry Based Case Study

Eligibility

Any Graduate/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

Programme Duration

The candidate is expected to complete the course in 3 months.

Registration

The registration dates for this executive programme run by the Institute are updated timely on the webpage. Effective online learning tools incorporated into the design of the webpage make the course. lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.

Programme Deliverables

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

  • – Assignments for all the programme modules for continuous evaluation and guidance.
  • – Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
  • – Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
  • – All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
  • – Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
  • – At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
  • – All learning and training delivery initiatives shall be conducted in English.

Examination & Certification

IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme. All the participants are obliged to appear for an online proctored exam at the end of the course. After successful completion, the participants will be awarded Certificate in Drug Safety Aggregate Reporting by IGMPI. For all the above-mentioned modules elaborate course material, self-assessment assignments and project work details would be provided by the Institute from time to time. Details get updated on the web page as well.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like Novartis, Dr Reddy’s, Quintiles, HCL, Kinapse, Fortis Health care, Novo Nordisk, Cognizant, TCS, Abbott, Jubiliant-Biosys, APCER, Wipro, Lambda, INC Research, etc. The IGMPI's Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare and Food industries on regular basis.

Future career prospects of Drug Safety Aggregate Reporting

As a Drug Safety Associate your role will be focused on the detection, evaluation, knowing and prevention of adverse effects (AE) of drugs. As Drug experts Professionals you need to update your skills and knowledge as per the most recent guidelines. This certificate course will help professionals, strengthening their skills and experience in this field.


Download Prospectus

Programme Fee Details

How to apply

For further enquiries, write to or call us on:
info@igmpiindia.org / 18001031071 (Toll Free), Phone: +91 11 26512850

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