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problogsposts · 11 months

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A Career in Pharmacovigilance & Related Training Programs

What is Pharmacovigilance?

Pharmacovigilance is known as drug safety in simpler terms. It is the science or technology of obtaining, monitoring, investing & analyzing information from healthcare service providers and affected individuals on the adverse reactions that from the use of medicine.

An adverse reaction can be defined as an unintended response to a drug or medical device that is meant for the prevention & treatment of a disease.

Pharmacovigilance is an employment option for medical, pharmacy, and science graduates. It is a scientific discipline that is involved with reporting & assessing the side effects of medicine.

Pharmacovigilance Course

There are certificate and diploma courses available for the students. Post Graduate Diploma in Pharmacovigilance is a specialized course. Graduate students are eligible for this course. In this course, students learn about the regulatory requirements of Pharmacovigilance. Pharmacovigilance is a branch of clinical research that has promising career opportunities in the future. The program also provides training on Pharmacovigilance.

Rainbow Clinical Research & Management is a leading education institute that provides online training & education programs in Pharmacovigilance. Specializations in Pharmacovigilance include safety administration & evaluation, data collection & organization, data mining & toxic signal identification.

Career in Pharmacovigilance

The implementation of the Pharmacovigilance system is growing in the healthcare sector in India. A career in Pharmacovigilance providing comprehensive and medical safety services including assessment of expectedness & drug ADR associations, medical evaluation, data mining and signal detection, and other specialized services. Specialization in Pharmacovigilance includes safety administration & evaluation, data collection & organization, data mining & toxic signal identification.

RCRM provides an Advanced PG Diploma in Clinical Research & Pharmacovigilance to develop a successful career in Pharmacovigilance. Students can apply for the Pharmacovigilance position of drug safety executive, Pharmacovigilance associate, regulatory affairs associate, medical safety associate, surveillance safety officer, safety administrator or specialist, or regulatory submission specialist. The industry offers an attractive package to Pharmacovigilance professionals.

Pharmacovigilance training

Pharmacovigilance training programs are for professionals working in clinical research, the pharmaceutical industry, and other related fields.

The Pharmacovigilance training covers various aspects of drug safety, including fundamentals of pharmacovigilance, signal detection and data mining, risk management, and mitigation, quality management & compliance, regulatory framework & guidelines, etc.

Some of the training programs that students can pursue to enter this industry are:

Professional Diploma in Pharmacovigilance

PG Graduate Diploma in Clinical Research and Pharmacovigilance

PG Diploma in Pharmacovigilance & drug regulatory affairs

PG Diploma in Pharmacovigilance & Medical Coding

PG Diploma in Pharmacovigilance & Data Management

#Pharmacovigilance course #pharmacovigilance job #pharmacovigilance training #pharmacovigilance services

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galagali23 · 4 years

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Entry in Europe API market and regulatory requirements

API manufacturer can enter the European market in two ways; viz Submission of CEP Dossier [Certificate of Suitability of European Pharmacopoeial monographs] to obtain CEP approval and Submission of ASMF [Active Substance Master File] in reference to formulator’s application.

For CEP submission, API should be listed in the European Pharmacopoeia. The responsible Regulatory Agency is EDQM [European Directorate for Quality of Medicines and Healthcare]. CEP being an independent application, API manufacturer can directly submit an application. This regulatory document is named as CEP Dossier. It is prepared in reference to EDQM guidelines and comprises of CTD Module 1, 2 and 3. Most of the API manufacturers from India are CEP holders. The fees for the new application is 5000 Euros. EDQM reviews the application and if found compliant, API manufacturer gets CEP approval through a certificate. CEP holder gets business in Europe and Canada, Australia, New Zealand, Tunisia and Morocco. It is also recognized by WHO. In addition to APIs, CEP is also awarded to Excipients, herbal products, TSE risk products

In case of ASMF submission, API can be pharmacopoeial or non-pharmacopoeial. The responsible Regulatory Agencies are EMA [European Medicines Agency] or other Eu agencies. This can be submitted only against MA [Marketing authorization] application of formulator i.e. Dependent on formulator. It is prepared in reference with ASMF guidelines of EMA and comprises of CTD Module 1, 2 and 3. There are no fees for 1st submission. However, MA applicant [Formulator] has to pay the fees. ASMF is reviewed in reference to MA application and if found complaint, name of the API vendor will be added to the MA certificate.

Though we have two ways, CEP is the most preferred option.

Key Responsibilities of Regulatory Professionals

The team preparing regulatory documents should be scientifically sound and aware of current Eu regulatory guidelines. They should also be able to submit the documents to the pertinent regulatory authorities within a specified time frame to get approval. Additionally, they have the responsibility to give training to the technical and business development team.

Certificate courses in Regulatory Affairs at IPM

To know more about European and other regulatory submission procedures, IPM is the best learning platform for the last 13 years.

Institute of Pharmaceutical Management (IPM) in Mumbai endows progressive post-graduate diploma in the realm of regulatory affairs to discover positions such as Regulatory affairs associate, Regulatory affairs executive, Regulatory affairs manager, to name a few. Its courses are self-paced and been intended by the industry specialists to fulfill the end-to-end requirements of tirelessly developing pharmaceutical companies and various other federal agencies.

IPM offer personalized classroom activities by way of a Tutoring Centre, Excellent Tutoring and other opportunities.

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