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Online Pharmacovigilance course

Online Pharmacovigilance course

Welcome to the Certification in Pharmacovigilance & Regulatory Affairs Courses (Online Pharmacovigilance course) conducted by the Bangalore Clinical Research Institute (BCRI). This 2-month program is specifically designed to equip participants with the necessary knowledge and skills to succeed in the field of Pharmacovigilance and Regulatory Affairs.

Pharmacovigilance and Regulatory Affairs are important aspects of the pharmaceutical industry, as they ensure that drugs are safe and effective for patients. With the increasing demand for pharmaceuticals, there is a growing need for professionals who are trained in Pharmacovigilance and Regulatory Affairs. This is where BCRI’s Certification in Pharmacovigilance & Regulatory Affairs Courses comes in.

The course will cover a wide range of topics related to Pharmacovigilance and Regulatory Affairs, including the following:

Introduction to Drug Discovery and Development: This topic will provide an overview of the drug development process, including the various stages of drug discovery, clinical trials, and regulatory requirements.

Introduction to Pharmacovigilance: This topic will introduce the concept of Pharmacovigilance, its importance in the pharmaceutical industry, and the various types of adverse drug reactions (ADRs) that can occur.

Regulatory aspects of Pharmacovigilance: This topic will cover the regulatory framework for Pharmacovigilance, including the guidelines and regulations that govern drug safety.

Reporting Criteria to Health authorities and timelines: This topic will provide an overview of the requirements for reporting ADRs to regulatory authorities, including the timelines for reporting and the information that needs to be included in the report.

PV Database Index: This topic will introduce the Pharmacovigilance database, its purpose, and how it is used in the pharmaceutical industry.

Drug Dictionaries, ADR dictionaries and Coding of the events: This topic will cover the use of drug dictionaries and ADR dictionaries in the coding of adverse events, including the various coding systems that are used.

Causality Assessment: This topic will provide an overview of causality assessment, including the various methods that are used to determine the relationship between a drug and an adverse event.

Narrative Writing: This topic will cover the requirements for writing a narrative report of an adverse event, including the information that needs to be included and the format for the report.

In addition to the above topics, the course will cover much more, providing participants with a comprehensive understanding of Pharmacovigilance and Regulatory Affairs.

One of the key benefits of joining the online Pharmacovigilance course at BCRI is the quality of trainers. The instructors who will be conducting the course are experienced professionals in the field of Pharmacovigilance and Regulatory Affairs, who have a wealth of knowledge and expertise. They will provide participants with the necessary guidance and support throughout the program, ensuring that they receive the best possible training.

In addition to the quality of trainers, there are many other benefits of joining the online Pharmacovigilance course. These include:

Flexibility: The online course provides participants with the flexibility to study at their own pace, from anywhere in the world.

Cost-effective: The online course is more cost-effective than traditional classroom-based courses, as there are no travel or accommodation costs.

Career opportunities: By completing the course, participants will have the necessary knowledge and skills to pursue a career in Pharmacovigilance and Regulatory Affairs, which is a growing and in-demand field.

Networking: Participants will have the opportunity to network with other professionals in the field, as well as with the trainers, which can lead to valuable career opportunities.

In conclusion, the Certification in Pharmacovigilance & Regulatory Affairs Courses offered by BCRI is an excellent opportunity for individuals who are interested in pursuing a career in Pharmacovigilance and Regulatory Affairs.

The course covers a wide range of topics, and provides participants with a comprehensive understanding of the field. The quality of trainers is exceptional, and participants will receive the necessary guidance and support throughout the program.

Joining the online Pharmacovigilance course at BCRI is a cost-effective and flexible way to gain the necessary knowledge and skills to pursue a career in the field. The growing demand for professionals in Pharmacovigilance and Regulatory Affairs makes this an excellent opportunity to enhance one’s career prospects.

To summarize, the Certification in Pharmacovigilance & Regulatory Affairs Courses offered by BCRI is an exceptional opportunity for individuals who wish to pursue a career in the pharmaceutical industry. The program covers a wide range of topics related to Pharmacovigilance and Regulatory Affairs, and the quality of trainers is exceptional. Participants will receive the necessary guidance and support to succeed in the field. Joining the online Pharmacovigilance course at BCRI is cost-effective, flexible, and offers numerous benefits, including career opportunities and networking.

Enroll in the program today to take the first step towards a rewarding career in Pharmacovigilance and Regulatory Affairs.

 

Tags:

Date

Apr 12 2024 - Jun 12 2024
Expired!

Time

8:30 pm

Local Time

  • Timezone: America/New_York
  • Date: Apr 12 2024 - Jun 12 2024
  • Time: 11:00 am

Cost

$349.00

Location

Online
Online
Online
Website
https://www.bcri.in/
Category

Organizer

BCRI-India
BCRI-India
Phone
8792590942
Email
[email protected]
Website
https://www.bcri.in/

Speaker

  • Mayuri Roy Sinha
    Mayuri Roy Sinha
    PV Trainer, Mentor For Academic & Corporates

    Executive Summary
    Mayuri Roy Sinha has 13 years of Pharmacovigilance experience, including 12 years of training. She has worked on multiple client projects and worked as Manager in Pharmacovigilance, where she handled multiple teams performing time-bound activities. She has independently handled both clinical trials as well post-marketing projects. Due to her passion for Training she has been involved with training activities throughout her career and has been a trainer for both new joiners as well as for experienced team members, including Pharmaceutical Clients.

    She is currently working as Freelancer Pharmacovigilance Trainer with multiple academic and corporate sectors. She is an NIIT Certified trainer. In her current role, She is part of both academic and corporate training, writing, and consultancy services in the pharmacovigilance domain. She understands the requirements of the organization and the candidates before imparting training. She is involved in content writing, course designing, conducting an assessment, interview preparation, practical classes and project work in line with work done in the Industry.

    Training ExpertiseShe delivers training on Pharmacovigilance Topics, Practical Work, Assessment, Safety Database, MedDRA Dictionary and doubt sessions for students. She also conducts technical interview mock sessions where She interacts with students and evaluates the level of clarity. Candidates can best utilize her professional experience to prepare themselves for Industry. She has handled multiple batches of both online and classroom sessions. She was a Project guide for BITS Mesra University Students in their final year Pharmacovigilance Project & handled 50+ batches so far.

    Technical ExpertiseShe has expertise in Pharmacovigilance Project Work, Handling various Individual case safety report processing and team management. She was extensively involved in Compliance management for Pharmacovigilance team, with expertise in audit handling, and training management.

    Projects handled:

    ICSR Team Management & Training: ICSR team management as per the compliance & quality, Compliance management for the partner company SLAs, Regulatory Submission, SOP preparation & review, safety database validation, handling data migration projects, Client meeting to identify the need for opportunity and training for performance enhancement, performance review (appraisals) of the team members, Handling end to end PV operation for clinical trial actives included but not limited to literature screening, regulatory site review.

    ICSR Team Management & Training: Pharmacovigilance Project guide for University students, Safety database training, PV theoretical training for multiple batches, designing course syllabus, preparation of question paper, conducting the workshop, journal club, presentation, University Final exam paper evaluation.

    Tools Stack
    Pharmacovigilance Safety Database including Arisg, Argus, AERS, PvEdge, PvNet
    MedDRA Dictionary
    Rave EDC

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