Advanced Program in Pharmacovigilance

Advanced Pharmacovigilance course is an integrated training program that clarifies the clinical research methodologies, clinical trials, drug development, and pharmacovigilance systems. You can strengthen your knowledge base and refine your skills to become a Pharmacovigilance and clinical research professional.

The advanced program enables trainees to analyze and organize data about the drugs’ side effort. Thus, trainees can apply their knowledge to make the right regulatory decisions on the available drugs.

By learning pharmacovigilance audit processes, a company can find out risks and gaps in their methodologies and systems. Thus, it becomes easy for an organization to establish compliance and define priorities.

As one of the participants of the training program, you will learn the technique for preparing the audit. Moreover, you can apply the best practices to get the desired result from the auditing process.

Scope of Pharmacovigilance

You can find different trends in the drug development sector. However, the most important thing is that drug safety must not be separated from innovations. The newly developed business models are getting more mature, and they can help in developing new-generation therapies. Thus, the healthcare sector constitutes both qualified products and newer drugs.

Pharmacovigilance is now one of the major factors of healthcare products’ lifecycle.  It is has become increasingly important to manufacturing more effective and safer drugs based on the latestregulations. The development, research, and marketing must also be compliant with these regulations.

Pharmacology curricula give higher importance to the need for learning about the safety of different medications. It will make the trainee aware of the pros and cons of medicines. It is a systematic approach to decision-making for therapeutic purposes. Irrational use of medicines results in adverse effects. Low-quality drugs and inaccessibility of the relevant drug details are the major problems. To avoid these issues, Pharmacovigilance is highly valuable.

Some global pharmaceutical companies have already created their pharmacovigilance centers. Local drug manufacturers also have stepped up their efforts with Pharmacovigilance. Thus, you can benefit your company by undergoing pharmacovigilance training.

Module 1: Introduction to Pharmacovigilance

• Understanding the concept of pharmacovigilance
• History and evolution of pharmacovigilance
• Importance and significance of pharmacovigilance in healthcare

Module 2: Regulatory Framework in Pharmacovigilance

• Overview of regulatory authorities and their roles
• Guidelines and regulations governing pharmacovigilance
• Compliance requirements and reporting obligations

Module 3: Adverse Drug Reactions (ADR)

• Definition and classification of adverse drug reactions
• Methods for detecting and monitoring ADRs
• Evaluation and causality assessment of adverse events

Module 4: Pharmacovigilance Systems and Databases

• Introduction to pharmacovigilance databases and systems
• Role of databases in signal detection and risk assessment
• Hands-on training with pharmacovigilance software

Module 5: Risk Management and Risk Minimization

• Principles of risk management in pharmacovigilance
• Risk minimization strategies and interventions
• Developing risk management plans and tools

Module 6: Pharmacovigilance in Clinical Trials

• Pharmacovigilance requirements in clinical trial settings
• Safety monitoring and reporting during clinical trials
• Role of pharmacovigilance in ensuring patient safety in clinical research

Module 7: Signal Detection and Management

• Understanding signals in pharmacovigilance
• Signal detection methodologies and algorithms
• Signal management process and procedures

Module 8: Pharmacovigilance Audits and Inspections

• Overview of pharmacovigilance audits and inspections
• Preparation for pharmacovigilance audits
• Handling findings and implementing corrective actions

Module 9: Pharmacovigilance Communication and Reporting

• Importance of effective communication in pharmacovigilance
• Internal and external communication strategies
• Reporting of adverse events to regulatory authorities and stakeholders

Module 10: Pharmacovigilance in Special Populations

• Pharmacovigilance considerations for special populations (pediatrics, geriatrics, pregnant women, etc.)
• Risk assessment and management in vulnerable patient groups
• Ethical considerations in pharmacovigilance research

Module 11: Future Trends and Emerging Technologies

• Emerging trends and advancements in pharmacovigilance
• Impact of artificial intelligence, big data, and digital health on pharmacovigilance
• Predictive analytics and forecasting in drug safety

Module 12: Case Studies and Practical Applications

• Analysis of real-world pharmacovigilance cases
• Practical exercises and simulations
• Application of pharmacovigilance principles in clinical practice

Module 13: Final Assessment and Certification

• A comprehensive assessment covering all course modules
• Successful completion leads to pharmacovigilance certification

Note: The course content is subject to updates and modifications to align with industry standards and regulatory changes. Participants are encouraged to actively engage in discussions and seek clarification on any topics of interest.

Who is Eligible For the Advanced Pharmacovigilance Training Course?

To be eligible for the course, you must have an advanced Post-Graduate Diploma in Pharmacovigilance and Clinical Research. Moreover, you need to have a degree in any of the following fields-

Bioscience/Life Sciences- Microbiology, Biochemistry, Genetics, Botany, Biotechnology, and Zoology

Medicine- BDS, MBBS, BPT, BHMS, BAMS, and  BUMS

Pharmaceutical Sciences/ Pharmacy

Bioinformatics / Chemistry / Biostatistics 

Allied Health / Nursing

When you are pursuing the final year of your graduation, you can apply for the Advanced Pharmacovigilance program.

Why Attend The Course?

• Increase your knowledge about global drug safety
• Make your team more capable and compliant with regulations
• Build a proper pharmacovigilance department for your drug manufacturing company
• Participate in workshop sessions to learn the way of applying legislation and ensure compliance

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FAQ

Who has to attend the Advanced Pharmacovigilance training course?

The comprehensive course on Pharmacovigilance will be highly beneficial to safety professionals working in the post–marketing safety field of the clinical sector. Professionals who need to deal with QA for auditing can make their careers brighter with this training program. The course includes different types of activities in the clinical safety department. Moreover, those who have multifunction responsibilities (like medical directors) in the healthcare industry can undergo this course.

What will you learn from the course?

At the end of the training program, trainees will gain the skills-

• To do a pharmacovigilance audit by analyzing risks
• Check a range of aspects with a system audit
• Manage the process audit
• Evaluate the audit documentation
• Manage complicated characters and missing documentation
• Follow-ups and reviews for the corrective actions
• Solve disagreements based on the audit result

Is it a self-learning training program?

Advanced pharmacovigilance course is available as a virtual training program. You can learn each of the modules at your own pace. We have designed every lesson carefully to make the content easily understandable.

Is there any technical requirement for the pharmacovigilance course?

You can use the latest version of any operating system, like Windows and Mac. You need to have a Java 5 processor for your Windows PC. Moreover, Mac users can use JavaScript and enable cookies. Make sure that you have a good internet connection speed on your device.