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.
Concepts surrounding coding conventions (such as MedDRA coding) will be introduced, followed by tips on writing clear narrative reports containing all relevant details to assist with medical assessment.
Attendees will learn about Australian and New Zealand local regulatory reporting requirements and explore different ways in which these can be met (including submitting reports and follow-up information electronically to the TGA).
Clinical trial requirements will be explored, including IND study requirements and the role of supplying safety reports to Investigators and Ethics committees. Attendees will discuss the sources of cases, including non-traditional sources such as online social media and market research. Pharmacovigilance requirements for Post-marketing Surveillance (PMS) studies will be introduced.
The course will also contain an overview of more in-depth pharmacovigilance functions, such as PSUR’s, RMP’s including the Australian Specific Annex (ASA) and Signal Detection including SSI’s and OSI’s.
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."
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
Continuing Professional Development (CPD) points
Upon completion of this workshop, attendees will receive 7 CPD points.
If you have any questions regarding your suitability for this workshop, please email or call the ARCS office on arcs@arcs.com.au or +61 (02) 8905 0829.
ARCS member - $805
Non-member - $1285
Virtual classroom
This workshop runs for one full day from 09:00-17:00 AEST
Attendee requirements:
Computer/laptop connected to power
Good internet access (1Mbps or better – broadband recommended)
A charged mobile phone and headphones (if using your phone for audio)
Phone charger – given the event goes all day, you will need a way of charging your phone
Headphones for computer audio (if using computer audio)
A quiet room/space
Before joining, be sure to check system requirements to avoid any connection issues
If you become a member of ARCS, you can enjoy member benefits such as discounted rates at courses/workshops/conferences/networking events and free access to the Interest Area meetings and members resources like the community forum. If you would like to become a member, please click here for more information. If you have any questions please contact arcs@arcs.com.au or ring +61 (02) 8905 0829
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