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Get Brochure to Your MailIntroduction to Pharmacovigilance Training in Bangalore
Overview of Clin Infotech's Pharmacovigilance Certification in Bangalore
Embark on a transformative journey in clinical research with Clin Infotech's Pharmacovigilance Certification course in Bangalore. Our program is tailored to provide participants with a comprehensive understanding of Pharmacovigilance, fostering the skills needed to thrive in the dynamic healthcare industry.
Live Project Practical-based Lab Environment
Clin Infotech takes pride in offering learners a cutting-edge Live Project Practical-based Lab Environment. This immersive setup ensures participants gain hands-on experience, enabling them to apply their knowledge directly to the technology they'll be using as experts in Pharmacovigilance.
About Pharmacovigilance Training in Bangalore
Certification Training Overview
In Bangalore, our Pharmacovigilance Certification training stands out as a beacon of excellence. Delivered by certified, experienced trainers in the Pharmacovigilance Department, the program is designed for those passionate about elevating their career in clinical research. Clin Infotech, known as one of the best Clinical Research and Pharmacovigilance training institutes, offers a meticulous course covering both theoretical and practical aspects of Pharmacovigilance with real-time scenarios.
Trainers' Expertise and Industry Recognition
Our trainers, considered among the best in the industry, bring a wealth of experience to the training sessions. Recognized for their expertise, they guide participants through the intricacies of Pharmacovigilance, ensuring they are well-prepared for the challenges of the field.
Thorough Knowledge in Theoretical and Practical Aspects
The Pharmacovigilance course content is crafted to provide a thorough understanding of both theoretical principles and practical applications. With industry subject matter experts contributing to the curriculum, participants gain insights that go beyond basic qualifications.
Course Ware Design by Industry Subject Matter Experts
The courseware is meticulously designed by industry subject matter experts, guaranteeing that participants receive top-notch education. The materials cover all aspects of Pharmacovigilance, ensuring a well-rounded education.
Additional Facilities Provided:
In addition to the training, participants receive valuable resources such as e-learning access, mock examinations, knowledge area-wise mock tests, and other facilities. Clin Infotech is committed to providing a holistic learning experience that extends beyond the classroom.
Eligibility Criteria for Pharmacovigilance Course in Bangalore
Professionals Suitable for Clinical Research Careers
Pharmacovigilance, being a critical aspect of clinical research, is suitable for professionals seeking to enhance their careers. Eligible candidates include:
- Pharmacy Professionals (B.Pharmacy/M.Pharmacy/Pharm D) with good analytical skills.
- Medical Professionals (MBBS/BDS/BPT/BHMS/BAMS/Nursing) - Freshers/Experienced.
- B.Sc/M.Sc graduates in Biotech, Microbiology, Biochemistry, Chemistry, and other life sciences.
Specific Eligibility Criteria for the Pharmacovigilance Course
While analytical and logical skills are advantageous, there are no specific prerequisites for enrolling in the Pharmacovigilance course in Bangalore. Clin Infotech welcomes individuals from diverse backgrounds, providing a comprehensive learning experience for both beginners and experienced professionals.
Pharmacovigilance Course Content in Bangalore
Comprehensive Curriculum Overview
Learning journey with Clin Infotech's Pharmacovigilance Certification course in Bangalore. Our comprehensive curriculum is thoughtfully designed to provide participants with a deep understanding of Pharmacovigilance, covering essential theoretical concepts and practical applications.
Key Modules
Welcome and Introduction
- Historical Overview
- Basic Principles of Pharmacovigilance in Clinical Trials
- Methodologies for Pharmacovigilance
- Pharmacovigilance Regulations in Clinical Research
Drug Development and Clinical Trial Phases
- Overview of Drug Development Phases
- Clinical Trial Phases and their Significance
- Pharmacovigilance Roles & Responsibilities in CROs & Sponsors
Pharmacovigilance Process & Life Cycle
- Understanding the Pharmacovigilance Life Cycle
- Roles and Responsibilities in the Pharmacovigilance Process
Introduction and Responsibilities: USFDA, EMA, and CDSCO
- Overview of Regulatory Agencies
- Understanding the Roles and Responsibilities of USFDA, EMA, and CDSCO
Pharmacovigilance in India
- Overview of Pharmacovigilance in the Indian Context
- Regulatory Landscape in India
Clinical Development Process
- Overview of Clinical Development
- Different Phases of Clinical Trials
Adverse Events and its Types
- Understanding Adverse Events (AEs)
- Different Types of Adverse Events
Drug Safety in Clinical Trials and Post Marketed Drugs
- Ensuring Drug Safety in Clinical Trials
- Post-Marketing Surveillance
Different Sources of Adverse Events Reporting
- Identifying Various Sources of AE Reporting
Different Types of AE Reporting Forms
- Overview of Various AE Reporting Forms
Expedited Reporting and its Timelines
- Understanding Expedited Reporting
- Timelines for Expedited Reporting
Different Departments Working on Pharmacovigilance
- Overview of Various Departments Involved in Pharmacovigilance
- Collaborative Approach in Pharmacovigilance
Roles and Responsibilities of Case Receipt Unit
- Understanding the Functions of the Case Receipt Unit
Roles and Responsibilities of Triage Unit
- Overview of the Triage Unit and its Significance
Four Factors for the Reportable Case
- Identifying the Four Factors for Reportable Cases
Seriousness Criteria of Adverse Event
- Understanding the Criteria for Serious Adverse Events
Expectedness or Listedness of Adverse Event
- Differentiating Expected and Listed Adverse Events
Causality Assessment of the Adverse Event
- Evaluating Causality in Adverse Events
Introduction to Safety Database and Different Types
- Overview of Safety Databases
- Types of Safety Databases
Narrative Writing
- Techniques and Practices in Narrative Writing
Case Quality Check, Medical Review, and its Submission
- Ensuring Quality in Case Processing
- Conducting Medical Reviews
The Qualified Person for Pharmacovigilance (QPPV) in the European Economic Area
- Understanding the Role of QPPV
PSUR and its Submission Timelines
- Overview of Periodic Safety Update Reports
- Timelines for PSUR Submission
Why This Curriculum Matters
Our curriculum not only covers theoretical aspects but also emphasizes the practical application of Pharmacovigilance concepts. By delving into real-world scenarios and industry best practices, participants gain a holistic understanding of Pharmacovigilance, setting the stage for a successful career in this dynamic field.
Why Choose Clin Infotech for Pharmacovigilance Course in Bangalore
Internship Program Details
In Bangalore, Clin Infotech's Pharmacovigilance Certification comes with an enriching internship program. Gain hands-on experience with the Argus Safety Database, participate in real CRO live projects, and receive real-time exposure to global drug safety software.
Course Material and Facilities Provided
Participants receive complete course material, including detailed information about the entire workflow of Drug Safety Associate. The course includes 2 months of internship after rigorous training, offering exposure to theory, case studies, and practicals.
Duration and Structure of Internship
The internship program spans two months, providing participants with a meaningful hands-on experience. It covers practical aspects like Case Processing, Narrative Writing, and MedDRA 16.1 & Who Drug Coding.
Industry-Based SOP's Training
Clin Infotech's internship includes training in industry-based Standard Operating Procedures (SOPs), ensuring participants are well-versed in the protocols and practices of the industry.
Trainers' Experience and Expertise
Trainers at Clin Infotech have a minimum of 7+ years of experience, providing participants with the guidance needed to navigate the complexities of Pharmacovigilance.
Total Exposure Hours to Theory, Case Studies, and Practicals
The program offers a total of 150 hours of exposure to theory, case studies, and practicals, ensuring participants are well-equipped with the knowledge and skills required for a successful career in Pharmacovigilance.
Pharmacovigilance Training Modules in Bangalore
Detailed Breakdown of Modules
Module 1: Pharmacovigilance Introduction
- Historical Overview
- Basic Principles of Pharmacovigilance in Clinical Trials
- Methodologies for Pharmacovigilance
- FDA and EU Perspectives
Module 2: Pharmacovigilance Regulations in Clinical Research
- Drug Regulatory Activities MedDRA
- Regulatory Aspects in Pharmacovigilance
- EudraVigilance
- Pharmacovigilance Regulations in Clinical Research
Module 3: Adverse Drug Reactions and Safety Reporting with ORACLE ARGUS
- ADR Reporting – An Introduction
- Causality Assessment of Suspected Adverse Drug Reactions
- Periodic Safety Update Reports (PSUR) for Marketed Drugs
- Expedited Reporting Requirements
- WHO & Safety Monitoring
Module 4: Case Processing and Narrative Writing
- Data Entry
- MedDRA/WHO-DRL/DD Coding of Reported Primary Diagnosis & Concomitant Medications
- Case Narrative Writing
- Query Generation and Forwarding
- Quality Control
Module 5: Compliance to Clinical Safety and Pharmacovigilance Regulations
- Review of Benefits-Risk Assessments and Management
- Scope of Pharmacovigilance Inspection and Conduct
- Internal Audit of Pharmacovigilance Activities
- Pharmacovigilance Inspection Reports
- Quality System in Pharmacovigilance
Pharmacovigilance Certification Process in Bangalore
Overview of Post-Training Examination
After completing the training, participants undergo an online examination facilitated by Clin Infotech to assess their understanding of advanced Pharmacovigilance concepts covered in the program.
Minimum Score Requirement for Certification
To successfully complete the certification, participants are required to achieve a minimum score of 60% or more in the online examination. This benchmark ensures a high level of proficiency in advanced Pharmacovigilance, positioning participants as competent professionals in the field.
Internship in Bangalore For Pharmacovigilance
Purpose of Internship
The internship program in Bangalore is meticulously tailored to serve a dual purpose. Firstly, it offers participants invaluable hands-on experience with cutting-edge software and immerses them in the intricacies of complete work processes. Secondly, it aims to empower students not just with theoretical knowledge but with practical skills that are crucial for success in real-world scenarios. The ultimate goal is to not only enhance the learning journey but also to ensure that participants emerge well-prepared to navigate interviews with confidence, giving them a distinct advantage in the fiercely competitive job market.
Interactive Elements and Evaluation
Our Pharmacovigilance internship in Bangalore is designed to transcend traditional learning boundaries. It introduces highly interactive elements, such as engaging case studies and authentic project scenarios, creating a dynamic learning environment. To assess understanding and proficiency, participants undergo mock exams meticulously crafted for each topic. This multifaceted approach ensures a holistic learning experience, catering to the diverse needs of both seasoned professionals and aspiring students. The course material, curated with precision, is not just informative but also structured for easy comprehension, fostering an atmosphere of continuous practical learning and skill development.
Mock Exams and Course Material Tailored for Easy Understanding
At Clin Infotech, we prioritize your learning experience. Our commitment to your success is reflected in our approach to assessments and course materials, ensuring a seamless and effective learning journey.
Invest in your success with our mock exams and thoughtfully designed course material, ensuring you not only pass your certification with flying colors but also acquire a deep and lasting understanding of pharmacovigilance principles.
FAQs (Frequently Asked Questions) about Pharmacovigilance Certification Course in Bangalore
Common Questions about the Pharmacovigilance Course
What is the duration of the Pharmacovigilance course?
The duration of the course is designed to provide a comprehensive learning experience and typically spans [duration].
Are there any prerequisites for enrolling in the course?
There are no specific prerequisites, making the course accessible to individuals from diverse backgrounds. Analytical and logical skills are advantageous.
How does the internship program enhance the learning experience?
The internship program offers hands-on experience, exposure to real projects, and the opportunity to apply theoretical knowledge in practical scenarios, enhancing overall learning.
What sets Clin Infotech's Pharmacovigilance course apart from others?
Clin Infotech's course stands out for its comprehensive curriculum, hands-on training, experienced trainers, and industry-specific SOPs, ensuring participants are job-ready.
How is placement support provided to students after completing the course?
The placement team at Clin Infotech assists trained professionals with resume preparation, interview preparation, mock interview sessions, and placement assurance.
Is there any flexibility in the course schedule?
The course schedule is designed to provide a structured and immersive learning experience, ensuring participants gain in-depth knowledge and practical skills.
Can the course be taken by individuals with no prior experience in clinical research?
Yes, the course is suitable for individuals with no prior experience. Clin Infotech provides a comprehensive learning environment for both beginners and experienced professionals.
Specific FAQs about Certification Process
How is the certification examination conducted?
The certification examination is conducted online, testing participants' understanding of advanced Pharmacovigilance concepts covered in the program.
What is the passing criterion for the certification?
To successfully complete the certification, participants must achieve a minimum score of 60% or more in the online examination.
Is the certification recognized in the industry?
Yes, the Pharmacovigilance certification from Clin Infotech is recognized in the industry, positioning certified professionals as competent and skilled in advanced Pharmacovigilance practices.