The enrolment for the Feb’14 batch of Professional Diploma in Clinical Research (PDCR) and Professional Certificate in Pharmacovigilance (PCPV) program is closing on 10-Feb-2014.Please send your Application Form by the due date in order to secure enrolment in Feb’14 batch
These training programs are aimed at imparting knowledge and skills required for clinical research and pharmacovigilance profession thereby enabling the participants to explore a career in these emerging streams. Optimal course fee and ease of training and evaluation has led to the wider acceptability of the programs amongst students and researchers.
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Program(s) Highlights |
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Clinical Research and PV Opportunities |
• Optimal Duration : 6 months correspondence program, requires approximately 80 hours of total reading.
• Assignment based evaluation, no written examination.
• Optimal Course Fee.
• Comprise of high quality study modules in line with the requirements of the clinical research and PV Industry.
• Wide recognition and acceptance of the program through out the industry making PDCR India's largest CR training program.
• Placement guidance provided to successful participants. |
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• Global Clinical Research (CR) industry is estimated at $52 bn ofwhich CRO marketsize is estimated at$17.8 bn.
• More than 2600 clinical trials are being conducted in India across 5000+investigator sites (ctri.nic.in)
• The Pharmacovigilance (PV) market worldwide was $1860 million in 2008 & is estimated to reach $2252 million by 2015.
• India is the fourth largest producer of pharmaceuticals in the world with more than 6,000 licensed drug manufacturers and over 60,000 branded formulations.
• In India more than 150 companies are actively engaged in Clinical Research and Pharmacovigilance field. |
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Professional Diploma in Clinical Research (PDCR) |
Module 1: Introduction to Pharmaceutical Medicine
- New Drug Discovery
- Clinical Development of Drug
- Essential Clinical Trial Documents etc.
Module 2: Good Clinical Practice (GCP) Foundations
- History of GCP - milestones in the evolution of GCP
- Principles of GCP
- Ethics in Clinical Research
- Biostatistics etc.
Module 3: Drug Regulatory Affairs (Clinical Trials)
- Overview of Regulatory Environment in USA, Australia, Europe & India
- Clinical Trial Application Requirements in India
- HIPAA Privacy Rule
- IND/ANDA/New Drug Application etc.
Module 4: Roles & Responsibilities of Clinical Trial Personnel
READ MORE >>>
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Professional Certificate in Pharmacovigilance (PCPV) |
1. Introduction to Pharmacovigilance (PV) and Risk Management
2. Standard Terms and Definitions
3. Global Perspective of PV and ADR Reporting
4. Guidelines and Standard Governing PV
5. Global AE Reporting System and Reporting Forms
- US FDA Form 3500 and 3500A
- Medicines and Healthcare Products and Regulator Agency's Vigilance Reporting Form-Yellow Card
- Medeffect Canada and Canada Vigilance Program
- Suspected Adverse Drug Reaction Reporting (SADRR) Form
- Universally Accepted ADR Reporting Form CIOMS I Form etc.
6. Individual Case Safety Reports (ICSRs)
7. Medical Dictionary for Drug Regulatory Activities (MedDRA)
8. Periodic Safety Update Reports (PSURs)
9. Expedited Reporting and Requirements
10. PV Inspection and Compliance Monitoring
READ MORE >>>
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Jobs & Opportunities after PDCR & PCPV
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Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Clinical Data Manager (CDM ), Drug Safety Associate (DSA) etc.
Highlights of PDCR and PCPV Programs:
Ease of Training and Evaluation: Distance learning mode and Assignments based evaluation
Optimal Duration: 6 months
Course Fee: Rs. 9600 each (DD in favour of Catalyst Clinical Services Pvt. Ltd. payable at Delhi)
Last Date of Enrolment: 10th February 2014
Follow the links below to download the Application Form. Our placement assistance can also be viewed on the same link,
<< DOWNLOAD APPLICATION FORM FOR PDCR >>
<< DOWNLOAD APPLICATION FORM FOR PCPV >>
Enrolment Procedure:
In order to enrol, one simply needs to send us the duly filled Application Form (available at the links above), copy of highest qualification certificate and DD of prescribed fee to the address mentioned in the footer of the Application Form.
Advantages of PDCR and PCPV Programs:
- Increases the visibility of your CV
- Equip you with the required knowledge to handle the potential interview questions
- Wide recognition and acceptance of the program(s) throughout the industry
- Placement assistance via regular job postings on CR Network
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Contact Details:
Catalyst Clinical Services Pvt. Ltd.
Corporate office:503, NDM-2, Netaji Subhash Place, Pitampura, Delhi – 110034, India
M:+91 9818356273; Ph: +91-11-45121445, 45121435
Email: info@catalystclinicalservices.com
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The National Institute of Pharmaceutical Education and Research has been established under the aegis of Ministry of Chemicals and Fertilizers, Government of India, Dept. of Pharmaceuticals as a Centre of Excellence in imparting higher education, research and development in pharmaceutical sciences and is the first Institute of its kind in country. The Institute was declared as an Institute of National Importance by Government of India through an Act of Parliament, notified on 26th June 1998. The Institute is a member of the Association of Indian Universities and Association of Commonwealth Universities.
