Pharmacovigilance

Pharmacovigilance

$60.00

This Pharmacovigilance training module (Certificate Course) introduces learners to regulations and ICH pharmacovigilance guidelines E2-E2F for monitoring and reporting on the safety and efficacy of pharmaceutical products.

The course content covers drug safety monitoring and reporting requirements from the earliest stages of drug development through to post-marketing drug safety surveillance responsibilities.

Who should take this course?

The Pharmacovigilance training module is suitable for both new and long-term employees, contractors, researchers, pharmaceutical industry suppliers, clinical trial personnel and life science professionals. It is ideal for anyone working in the pharmaceutical sector. This includes professionals involved in quality assurance and quality risk management (QRM), CAPA investigations, manufacturing, and/or pharmaceutical and medical device product marketing.

This Certificate Course (available online) makes an excellent induction course and/or GMP refresher course when combined with onsite training.

What you’ll learn in this newly released online GMP Certificate Course:

  • Safety surveillance requirements for the safe use of pharmaceuticals (drug safety)
  • Adverse drug reactions recording and reporting requirements (pre-and post-marketing surveillance)
  • Serious adverse events (SAEs) reporting requirements in relation to pharmaceutical products including investigational medicines (such as cannabis-derived medicines), medical devices (such as pacemakers, prosthetics, SaMD), and/or vitamin supplements in certain regions
  • ICH Pharmacoviglance guidelines
  • Differences between ICH guidelines and TGA guidelines for Pharmacovigilance
  • Pharmacovigilance guidelines by the TGA in Australia
  • FDA Pharmacovigilance guidelines
  • EMA Pharmacovigilance guidelines
  • MHRA Pharmacovigilance guidelines
  • Pharmacovigilance audits and compliance guidelines (what you need to know to prepare your team for compliance)
  • Case studies

Description

Pharmacovigilance Training Course: online training

Pharmacovigilance Certificate Course

This newly released module includes information on Pharmacovigilance guidelines (pharmaceutical safety monitoring and reporting requirements) including SAE identification and reporting requirements.

This Certificate Course includes introductions to drug safety regulations across a variety of countries.

It includes an overview of regulations and specific pre- and post-marketing pharmaceutical safety surveillance compliance requirements from the FDA, TGA, EMA, MHRA and ICH Guidelines for Pharmacovigilance and ADR/SAE reporting.

Examples of Pharmacovigilance requirements included in this course: TGA Pharmacovigilance guidelines, FDA Pharmacovigilance guidelines, and regulations for ongoing safety monitoring in the EU (EMA) and UK (MHRA).

 

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This well-rounded Pharmacovigilance training course an excellent resource for individuals needing an introduction to (or refresher course in) ICH guidelines for Pharmacovigilance and efficacy reporting.

This Pharmacovigilance Certificate Course includes pharmaceutical safety monitoring and reporting responsibilities from the TGA’s guidelines for pharmacovigilance (which vary slightly from the ICH guidelines) and examples from regulatory agencies in the US (FDA), UK (MHRA), and the EU (EMA).

The module can be taken as an individual certificate course. It is also an adjunct to the herbal medicines Clinical Trials training course and/or pharmaceutical GMP training bundles including PICs Annexes 1-20 online training courses.

Who should take this Pharmacovigilance course?

  • The online training course for Pharmacovigilance compliance is suitable for a variety of professionals working in public health, pharmaceutical safety, medical device and pharmaceutical quality management systems (QMS), quality risk management (QRM) roles, and medical device manufacturing safety surveillance including database management and reporting roles.
  • It covers guidelines and responsibilities for pre-marketing approval pharmacovigilance (Clinical Trials Phase I-III) as well as guidelines and regulatory requirements for post-marketing (Phase IV) pharmacovigilance systems.

Learn more about complying with pre-marketing pharmacovigilance requirements and adverse event reporting responsibilities (e.g. required during early investigational phases of clinical trials) as well as post-approval marketing safety monitoring and reporting requirements.

Examples of pharmacovigilance governance are provided, referencing the relevant Regulatory Authority in different regions – with examples focusing on Australia (TGA), the United States (US FDA), the Europe Union (the EU EMA) and the UK (MHRA).

Pharmacovigilance (meaning): post-marketing pharmaceutical safety/drug safety surveillance, which focuses on the identification, reporting/data collection, safety signal analysis, adverse reaction and adverse event reporting relating to Pharmaceutical products including medical devices (and vitamin supplements, depending on the region), and more.


What’s covered in Pharmacovigilance online training module:

  • General requirements for monitoring and reporting on the safety of pharmaceutical products
  • Guidelines and responsibilities for identifying, recording and reporting adverse drug reactions (AREs), adverse events (AEs), serious adverse events (SAEs), and suspected ‘unexpected serious adverse reactions’ (SUSARs).
  • Authorities and regulations that oversee pharmaceutical safety monitoring and reporting requirements (regulatory agencies such as the TGA (Australia), FDA (United States), EMA (European Union), MHRA (UK).
  • Introduction to Pharmacovigilance Guidelines published by the International Council of Harmonization (ICH) 

Education purposes only: Online pharmaceutical industry induction and GMP refresher courses are best used in conjunction with additional onsite pharmacovigilance training and onsite GMP compliance monitoring.


Pharmacovigilance Training Course Duration for Certificate of Completion

 

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Average online training course completion time frame

Allow from 2.5 to 4 hours to complete this online Pharmacovigilance Training module including the Final Assessment.
However, learning times vary from person to person and depend on numerous factors, such as pre-existing knowledge and familiarity with the topic, individual learning styles and learning capacities, personal or professional time commitments and disruptions, internet reliability, depth of topic content, and many other factors.
This means Certificate Course completion times can vary from person to person and from course to course.

How to complete this training course in Pharmacovigilance

  • Scroll up to add this purchase to your basket and then complete the check out process for this online course
  • Next, check your emails (including your filtered folders) for an email with your login details, which should arrive fairly quickly to your email inbox (ensure you use your correct email address).
  • If you don’t see this in your inbox, search your mailbox folders for ‘onlinegmptraining’ and/or ‘course’ and/or ‘Pharmacovigilance’.
  • Then log-in and begin your Pharmacovigilance training.
  • You will have access to the course for 12 months – one licence, one user, once Certificate per each module completed.
  • You can complete the course in multiple sittings or complete the training all at once. But you’ll gain access immediately upon completing your online purchase of the module. Single user licence only.  Access continues for 12 months from date of purchase.

Pharmacovigilance Certificate

  • For education purposes only.

    The Certificate of Completion is not a statement of competence but affirms you completed the online Pharmacovigilance course.

  • This training is for education puposes only and is designed to supplement your specific onsite training, induction training and direct Supervision for pharmacovigilance and other drug safety regulation compliance in your workplace.
  • You can download, print and/or email your Certificate of Completion after successfully completing the final assessment of this certificate course (online).