Skill Development Programme on Pharmacopoeial Standards for Pharmaceuticals (PSP) & Pharmacovigilance for Medical Products (PvM)- 2019 at Indian Pharmacopoeia Commission



Indian Pharmacopoeia Commission (IPC) is an Autonomous Institution of the Ministry of Health and Family Welfare, Govt. of India. IPC is created to set standards of drugs in the country. Its basic function is to update regularly the standards of drugs commonly required for treatment of diseases prevailing in this region. It publishes official documents for improving Quality of Medicines by way of adding new and updating existing monographs in the form of Indian Pharmacopoeia (IP). It further promotes rational use of generic medicines by publishing National Formulary of India. IP prescribes standards for identity, purity and strength of drugs essentially required from health care perspective of human beings and animals. IPC also provides IP Reference Substances (IPRS) which act as a finger print for identification of an article under test and its purity as prescribed in IP.

Skill Development Programme on Pharmacopoeial Standards for Pharmaceuticals (PSP)

• To develop or enhance skills/ technical knowledge of participants in new Pharmacopoeial standards to prepare them to strengthen the quality medicine for betterment of health of Indian and global population.
• To broaden experience of an area of work of participants with an opportunity to learns analytical and Pharmacopoeial concepts.
• To create the awareness about the present scenario of development of drug standrads and to better understands the regulatory aspects.

• Graduate/ Post Graduate, Research Students of Pharmacy, Science, Applied Sciences, technology and engineering.
• QC/QA/ Regulatory personnel from pharmaceutical industry
• Technical persons from drug regulatory authority
• Academicians

• Employment opportunities in analytical laboratories in Government & Private sector.
• Carrier opportunities in regulatory system and CROs
• Acquiring basic knowledge in Pharmacopoeial education

• Able to strengthen the skills on various modern sophisticated methodology in Pharmacopoeia.
• Able to understand the basic requirement of Good Pharmacopoeial Practices.
• Able to correctly compile and interpret the analytical data and data integration.
• Be aware in the field of drug standard development with regard to regulatory aspects in present scenario.

• The training programme is designed in a systematic way such that the classroom presentations were followed by the hands on training on Pharmacopoeial Monograph development and harmonization.
• Topics included in the curriculum will cover all the facts of professional and personal challenges for the analyst.
• Training will include presentation from various experts in different discipline from all over the country.
• Pre assessment and post assessment of participants is done to evaluate the effectiveness of training programme.

Skill Development Programme on Pharmacovigilance for Medical Products (PvM)

The objective of this skill development programme is to enhance Pharmacovigilance Knowledge and skills of the health care professionals, which in turn promote patient safety.

Target group
• Young Pharmacy/Medical/Paramedical professionals seeking care Pharmacovigilance
• Existing professionals in Pharmacovigilance

Career prospects
• Employment opportunities in Pharmacovigilance in Government & Private sector.
• Career opportunities in regulatory system/CROs and public health programmes.
• Abilities to deliver Good Pharmacovigilance Practice at par with international requirement.
• Providing a platform for being an entrepreneur in PV.

Expected Outcomes:
• Acquiring basic knowledge in Pharmacovigilance.
• Creating a workforce at National/International level to meet challenges in PV
• Enable and mobilize a large number of health care professionals to take up training and acquire requisite skills for employment
• Capacity building and strengthening of QPPv (Qualified Person for Pharmacovigilance) as per the requirement of the schedule Y of D&C Act.

Course Content:
• Pharmacovigilance: Basics, Objectives & Methods
• ADRs: Understanding, Prevention & Reporting
• Understanding of Individual Case Safety Reports (ICSR).
• Hands on training on ICSR processing
• Pharmacovigilance Programme of India
• Materiovigilance Programme of India
• Causality Assessment & Quality review
• Role in Public Health Programmes
• Signal Detection & Assessment
• PV based Regulatory Action - Application of IT tools
• Adverse Events Following Immunization(AEFI)
• Periodic Safety Reports: PSURs/PBRERs

How to Apply
Interested candidates may send their application form in prescribed format available on The duly filled application form along with updated resume & bonafide certificate from their Institution/ Organization to be submitted via email at Application shall be processed on “First come first serve basis”.

Renowned experts from-
• Government Teaching & Corporate Hospitals
• Regulatory Authority
• Pharmaceutical Industries
• Academic & Research Institutions
• Testing Laboratories

Training Fees:
SDP on Pharmacopoeial Standards for Pharmaceuticals (PSP) : Rs. 5000/- (Rs.4235+18% GST)
SDP on Pharmacovigilance for Medical Products (PvM) : Rs. 5000/-(Rs.4235+18% GST)
SDP on PSP + SDP on PvM (10% concession) : Rs. 8995/- (Rs. 7623+18% GST)

Fees includes
• Resource material (Electronic/Printed)
• Field visits
• Lunch & refreshments during training sessions.

Venue: Indian Pharmacopoeia Commission, Rajnagar, Sector 23, Ghaziabad
• 201002 Note: Aspirants have to make their own arrangements for traveling & lodging.

Duration of the training Programme:
Duration of the training programme is 5 days and the training is available round the year as per training calendar.



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