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Executive Diploma in Clinical Research


Keeping all needs and requirements of the industry, founders of IGMPI and successful professionals from CR industry have taken pain and with huge efforts brought to light a regular course to cater all needs of CR industry and its aspirants. IGMPI thus, after effective research and mind boggling sessions with people working in the CR industry have successfully laid forward a comprehensive Executive Diploma course in Clinical Research.

With this course, the aspirants will be appropriately equipped to face any and every challenge the industry throws to them. The course offers:

  • Subject learning;
  • Work knowledge of each face of the CR industry
  • Case study based approach ensures on-field problem handing;
  • Training in professional etiquettes, ethics and varied working tools of the industry.

    Course Modules :

    Module 1: Introduction to Clinical Research Industry and Basics of Clinical Trials

    Module 2: Pharmacology-Concepts and Application in clinical trials

    Module 3: Drug Development Process

    Module 4: Ethics and Ethical Guidelines for Clinical Trials, and Drug Development Industry

    Module 5: Regulations Guiding the Clinical Research Industry- History and Basics of National and International Regulatory Bodies

    Module 6: Outsourcing Clinical Trials, functioning of Clinical Research Organisations

    Module 7: Biostatistics- Concepts and Application in Drug Development and Clinical Research

    Module 8: Clinical Trials- Phases and Trial Designs

    Module 9: Documentation and Data Management in Clinical Trials

    Module 10: Safety Reporting Techniques and Pharmacovigilance

    Module 11: Quality Control and Clinical Trial Management

    Module 12: Clinical Trials- Medical Devices

    Module 13: Protocol Writing and Designing

    Module 14: -Clinical Trials -Latest updates : New Drugs and Clinical Trials Rules, 2019

    Module 15: Industry Based Case Studies

    Experimental training

    1: Preparation of clinical trial protocols and final clinical trial reports

    2: INDA, NDA, BLA, Informed consent form filling

    3: Preparation of PSUR for submission in EU

    4: Preparation of CTD/eCTD dossiers for submission in regulatory agency

    5: Preparation of an IMPD for EU submission

    6: Designing case report forms and EDC

    7: Drug development process and its filing

    8: Biostatistics

    9: Training on CTMS

    10: Preparation of SOPs and work manuals for quality trial management

    Experimental training along with the lectures from expert professionals will help the participant to learn the practical aspects of clinical trial process. After the course completion, the participant is expected to have extensive and up-to-date knowledge of clinical research industry and pharmacology, PSUR for adverse reaction reporting, filling process of India and International countries -NDA, INDA, EDC, CTD/eCTD, IRB, BLA and Informed Consent Form, Clinical Trial Management System (CTMS), preparation of protocol and case report forms (CRFs), etc.

    Eligibility

    All those working in the Pharmaceutical Industry or any sector of Healthcare industry or any other industry type (India) can apply for this short term programme. Life Science graduate/ B.Pharm/M pharm/MSc/ students pursuing or passed outs of Clinical Research degree or diploma courses are also eligible for the course. Working professionals of any of the following industry types Food manufacturing, Food Ingredient and Additive processing, Drugs manufacturing , Medical Device, Ayurveda, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurveda Medicine Manufacturing, Cosmetic Manufacturing, Biotechnology or any related industry are highly encouraged to apply for the programme.

    Programme Duration

    The programme duraion is 6 months.

    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 recorded lectures on all key areas of the programme giving all flexibility to the participants.
  • 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.
  • Registration

    The registration dates for this bi-annual programme run by the institute are updated timely on the webpage. The Training sessions and webinars are scheduled preferably on weekends depending on the availability of visiting faculty.. Effective E-learning tools incorporated into the design of the webpage make the course lectures, videos and study material easily accessible. This gives huge window of self-regulated and self-paced performance to the participants.

    Internship

    All the efforts will be made in the form of 3 months internship to provide industrial exposure to the students through internship with pharmaceutical company so that they can have good practical knowledge beyond the classroom experience.

    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 annual exam at the end of the course. After successful completion, the participants will be awarded Executive Diploma in Clinical Research. For all the above mentioned modules elaborate course material and project work details would be provided by the Institute from time to time. Details get updated on the webpage as well.

    Placement Assistance & Corporate Relations

    The Institute has partnered with many organizations for providing with placement assistance to in its participants. The robust placement cell comprises of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. We are engaged in promoting the employability of our participants by maintaining good rapport and relation with HR cell and recruiting managers of leading healthcare companies across the globe.

    The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc.

    In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like Dr. Reddy’s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, Ipca Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, Accenture, Wipro, Fortis Clinical Research, Quintiles, SeQuent, PepsiCo India, Mankind, Beryl Drugs, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Biocon, Apollo Hospitals, etc.

    Future career prospects of Clinical Research Training

    IGMPI offers professional and industry oriented training in Clinical Research thus opening doors for entry into the industry. PG diploma in CR adds advantage for those already in the industry as a tag of professional training and those new to the industry feel comfortable with backing of apt and up-to-date information and training required to sustain and grow in the industry.

    PG Diploma in Clinical Research is a broad spectrum course which offers to entail the candidate with knowledge and practically important information about the industry type, working modalities, methodology of trials, techniques of quality control, drug development, post marketing safety checks and all other aspects related to the clinical research industry. With the completion of this course the candidate gets to select from varied work areas of the industry/sector of his/her interest. Knowing all faces of the industry, candidate can target to specifically enter the drug development, CTs, Data Management, Regulatory Affairs, Quality Assurance or Post marketing Surveillance teams of various Pharmaceutical companies. Same is true for the professionals who are already a part of the industry but are keen on making lateral movement in their company by shifting to other department.


    Programme Fee Details

    How to apply

    For further enquiries, write to or call us on::
    info@igmpiindia.org/ +91 8587838177, +91 8130924488, 0120-4375280

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    Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like