ICRI Campus
Course Description
This program is an award-winning programme and is India’s first & till date the most sought-after programme within the science fraternity, offering a PG Diploma in Advance Clinical Research and a Post Graduate Diploma in Pharmacovigilance.
PG Diploma in Advance Clinical Research consists of various human experiments and studies. It is a broad concept with various components, such as clinical research activities, drug management research, drug manufacturing, determining the right dosages of medications for human consumption, and effects of particular medications on the human body, among others. These components are critical to the curriculum of the Post Graduate Diploma in Clinical Research.
The PG Diploma in Advanced Clinical Research offers an advanced study of the sub-disciplines of epidemiology, data management, and biostatistics. Along with the curriculum's theoretical components, this programme also focuses on teaching students how to use their knowledge and skills in the real world. This is similarly emphasized in the PG Diploma in Pharmacovigilance.
The comprehensive curriculum enhances the avenues available to students when they step into the industry for faster career scope when you pursue Post Graduate Diploma Advance Clinical Research.
The mix of Clinical Research, Clinical Data Management, Medical Writing, and Pharmacovigilance curriculum along with Management Module and Soft Skills in the course ensures a head start to move up the corporate ladder faster, especially for those pursuing a Post Graduate Diploma in Pharmacovigilance or a PG Diploma in Clinical Data Management.
Industry
The global clinical trials market size was estimated over 50.0 billion in 2022 and is expected to reach USD 84.43 Bn by 2030 with a registered CAGR of 5.7% during the forecast period 2022 to 2030. The market was further driven by the COVID-19 pandemic and the importance of making India a hub for conducting clinical trials. The large number of patients also highlights the growing demand for treatments and immunizations. Currently, 288 medicines and 106 vaccines are in various stages of development, with almost 7.0% of therapeutics in Phase IV, 21.0% in Phase III, and 43.0%, 13.0%, respectively in Phase II and Phase I.
The market was further driven by the COVID-19 pandemic and the importance of making India a hub for conducting clinical trials. The large number of patients also highlights the growing demand for treatments and immunizations. Currently, 288 medicines and 106 vaccines are in various stages of development, with almost 7.0% of therapeutics in Phase IV, 21.0% in Phase III, and 43.0%, 13.0%, respectively, in Phase II and Phase I.
A new set of rules in place since 2019 is beginning to make India an attractive destination for big pharma to conduct clinical trials.
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These rules have brought India's regulatory framework on par with U.S. Food and Drug Administration (FDA) norms and now India is among the top choices for global clinical trials. India's clinical trials market is expected to reach $3.15 billion by 2025 with a compounded annual growth rate of 8.7%. A new set of rules in place since 2019 is beginning to make India an attractive destination for big pharma to conduct clinical trials in India. Today, around 50,000 clinical research professionals are required in the clinical research industry, many of whom can benefit from a diploma in clinical research.
Today, around 50,000 clinical research professionals are required in the clinical research industry..
Curriculam
SEMESTER I
- Module I – Introduction to Clinical Research
- Module II – Basic Pharmacology and Pharmacy in Clinical Research
- Module III – New Drug Development
- Module IV – Ethical Guidelines in Clinical Research
- Module V – Ethics in Clinical Research
SEMESTER II
- Module VI – Regulations in Clinical Research
- Module VII – Biostatistics in Clinical Research
- Module VIII – Specialist Clinical Trials and Clinical Trial Designs
- Module IX – Clinical Trial Documentation
- Module X – Quality in Clinical Trials
SEMESTER III
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Module XI – Clinical Data Management
Module XII – Clinical Trial Management
Module XIII – Drug Safety and Pharmacovigilance
Module XIV – Soft Skills for a Clinical Research Professional
What You Will Become after Pursuing Pharmacovigilance Course?
For Doctors:
Principal Investigators / Co-investigator / Medical Advisor / Drug Developers / Regulatory Affairs Manager / Clinical Research Physician.
For Paramedics, Pharmacists & Life Science Graduates:
Medical Writers / Clinical Research Associates / Site coordinators / Clinical Research Manager / Drug Development Associates / Clinical Data Management / Pharmacovigilance Executive / Clinical Trial Analyst / Drug Reviewer / Drug Safety Physician & many more.
For Management Professionals (with Life Science/Health Science background):
Business Development / Clinical Project Management / Clinical Research Management / Regulatory Affairs.
Clinical Research Associates:
Monitor clinical trials, ensure compliance with the clinical trial protocol, check clinical sites activities, make on-site visits, CRFs.
Clinical Research Investigators:
Conduct BA/BE studies, writing/revising SOP, review protocols, investigators brochures, ICF & CRFs Protocol, CRF & ICF preparations plans, and conduct of BA/BEIEC/IRB affairs-GC.
Study Coordinators:
Provide safety & protection while collecting & managing the study data.
Data Manager / Biostatistician:
Design, study & predict the seriousness of the disease, evaluate new treatment and effectiveness of medication, participate in research design, data collection, choosing & implementing appropriate methodologies, interpreting the results.
Regulatory Affairs Managers:
Review & registration of documents, evaluation of technical data, liaison with regulatory authorities.
Clinical Trials Auditors:
Conduct audits for regulatory functions within the trial department to assure compliance with GLP/GCP in accordance with established FDA regulations and company policies & standard operating procedures.
Clinical Research Managers:
Manage, supervise, train, mentor clinical research staff, approve investigator’s study, budget & contract, review & approve regulatory documents, develop protocol, approve CRFs, review study data.
Business Development Manager:
Identify potential clients, establish business relations, responsible for meeting new clients, following up on leads, market research.
Drug Safety Associate:
Manage & relay drug safety information, maintain current knowledge of global drug safety regulations, summarize clinical safety data, write narratives with medical input, report SADRs to Regulatory Authorities, participate in training on drug safety issues & other tasks under drug safety.
Medical Writer:
Documentation, manuscripts, abstracts, external communication tools.
Clinical Data Manager:
Ensures the accuracy & consistency of data prepared for regulatory bodies for reporting purposes.
Others:
Auditors, Quality Assurance, Patents & IP Related positions.
What are the fantastic career Prospects of doing a PG Diploma in Pharmacovigilance?
Pharmacovigilance is a popular field of study these days. This field focuses on assessing, detecting, and comprehending harmful effects and preventing them. The Post Graduate Diploma in Pharmacovigilance is a well-known course that can be pursued at many reputable colleges in India and abroad. This course professionally prepares students to excel in this field and establish a solid career in pharmacovigilance. Numerous colleges provide this course to students. Students can now take this pharmacovigilance course in Pune, which is very advanced and convenient. The pharmacovigilance course is becoming increasingly popular due to its numerous advantages.
The Post Graduate Diploma in Pharmacovigilance has been designed by industry experts, ensuring comprehensive coverage and understanding of the industry and its functional areas. The Post Graduate Diploma Programme aims to familiarize participants with the most recent theoretical and practical aspects of the course in Pharmacovigilance. The diploma program has the following enticing features to benefit all program participants:
- Improved industrial training and abilities
- Increased industry knowledge
- Practical and professional training in industry regulations and work processes
- Firm grip on the PV industry's framework, resulting in the availability of the best job opportunities.
Pharmacovigilance Training's Future Career Prospects: ICRI provides professional and industry-oriented Pharmacovigilance courses in Pune, paving the way for entry into the industry. A PG Diploma in Pharmacovigilance course offers an advantage for those already in the sector as a badge of professional training, while those new to the industry feel at ease with the backing of appropriate and up-to-date information and training required for sustained growth in the industry.
The PG Diploma in Pharmacovigilance is a comprehensive program that provides candidates with knowledge and practical information about the industry type, working modalities, methodology used, quality control techniques, and drug development. Still, the overall emphasis remains on the course in Pharmacovigilance. This includes a thorough investigation of various types of adverse effects, serious adverse effects, adverse effects reporting regulations, documentation methods, and so on. After completing this program, the candidate can choose from various job opportunities in the industry/sector of their choice. Additionally, for individuals seeking broader expertise, courses such as a diploma in clinical research, PG Diploma in Clinical Data Management, and Post Graduate Diploma in Advanced Clinical Research can be pursued alongside the Post Graduate Diploma in Pharmacovigilance for a well-rounded education in the field. .
Where Will You Work ?
Bioengineering Companies
Serum Institute Of India, Panacea Biotech Ltd, GlaxoSmithKline, Bharat Serums.
CROs
Excel Lifesciences, Clinigene, IQVIA, PARAXEL, Panacea.
Hospitals
Apollo, Max, Fortis, etc.
Life-Division of IT Companies
Accenture, TCS, Cognizant, etc.
Pharma Companies
Cipla, Novartis, Ranbaxy.
Medical Device Companies
Abbott Laboratories, Johnson & Johnson, Novartis AG, Siemens Healthineers, General Electric.
Medical Colleges
AIMS, BAMC, Maula AZAD, Mahavir Medical College.
Cosmetic Companies
Biotique, Lakme, Sugar Cosmetics, Mama Earth
