Login

Register

  • Dates

  • Topics

  • Formats

  • Organiser

Organiser: LifeSciences Australia (formerly ARCS Australia)

For practising Regulatory Affairs, Clinical or Drug Safety/Pharmacovigilance associates

Embark on a further exploration of pharmacovigilance through the "Pharmacovigilance in Practice - The Pharmacovigilance Professional" training course at ARCS Australia. This meticulously designed program follows on from the first course “An Introduction to Pharmacovigilance” and equips participants with a profound understanding of safety data collection, reporting processes, and the fundamental principles of pharmacovigilance. From navigating the historical significance of the CIOMS-I report to mastering the intricacies of case coding, participants gain practical skills crucial for effective safety reporting. The course extends its coverage to encompass investigator-initiated studies, non-interventional studies, and the evolving landscape of pharmacovigilance in the context of market research, social networking, and social media.

Moreover, the curriculum delves into signal detection concepts including Significant and Other Safety Issues (SSI’s/OSI’s), regulatory obligations such as Periodic Safety Update Reports / Periodic Benefit Risk Evaluation Reports (PSUR’s/PBRER’s), Development Safety Update Reports (DSUR’s), Risk Management Plans (RMP’s), and safety reporting for compassionate use and Special Access Scheme/s29 programs. Discussions on the Pharmacovigilance Quality Management System and the importance of preparation for audits and inspections provide a holistic view of industry best practices. By the course's conclusion, participants emerge well-prepared with a robust skill set, positioning them to excel in the dynamic and critical field of pharmacovigilance, contributing to enhanced drug safety and regulatory compliance.

Who should attend:

This workshop is intended for practising Regulatory Affairs, Clinical or Drug Safety/Pharmacovigilance associates with 2 years or more experience. There is an assumed knowledge of terminology and processes as outlined in the ARCS workshop "An Introduction to Pharmacovigilance."

Learning objectives:

By the end of this workshop delegates will be able to:

  • Collect and handle data for cases in accordance with applicable laws and regulations
  • Process and document a case ensuring that it is coded, narrated and assessed appropriately
  • Assess Safety Issues as Significant (SSI) or Other (OSI)
  • Understand the requirements of a PSUR, DSUR, RMP and ASA
  • State the regulations that govern the collection and reporting of cases to the Australian and New Zealand Health Authority
  • Discuss the role of pharmacovigilance in protecting the product and ultimately the company
  • Discuss the impact of new developments in pharmacovigilance on the role of pharmacovigilance personnel

 

Facilitator Information: 

Bianca Joo | Director, Pharmacovigilance Country Head - Australia / New Zealand | Moderna

Corrin Shepherd | Director, Cluster Safety Lead - Australia / South Asia | Pfizer Australia

Register Now
Available Dates

Reading this content is completely free

Enjoy Unlimited Access and Unlock
Additional Features with a Free Account

Join Now

You are attempting to log out of MyMA

Do you really want to log out?

Logout
Close