The overall aim of the 1 day workshop is to enable attendees to gain an understanding of the role and function of Pharmacovigilance and how the role Pharmacovigilance has in proactively managing the safety profile of a product.
Pharmacovigilance is the science relating to the detection, assessment, understanding and prevention of the adverse effects of medicines. When Hippocrates in 500BC stated 'PRIMUM NON NOCERE' or 'First, do no harm' he could not have envisaged the central role that Pharmacovigilance would have in assisting physicians meet this cornerstone of medicine.
The ARCS Introduction to Pharmacovigilance workshop will provide delegates with an understanding of the importance of the role of Pharmacovigilance in the drug development process and life cycle of a therapeutic good.
The workshop analyses the role of Pharmacovigilance throughout the product lifecycle. It explores the legislative and corporate government requirements that are essential to this role and function. In addition, key processes for the management of adverse events are reviewed, in both the clinical trial environment and post authorisation environment. Delegates will learn how ultimately the science behind Pharmacovigilance in the safety management of a product when effectively applied can minimise risks and meet our primary directive which is to prevent harm to the patient.
Advisory Board and Expert Consultants:
Stephanie Chow (Pfizer)
Andrew Cooper (CSL)
Theresa McGarry (Celgene)
Rodney Peters (Baxter)
Geraldine Peterson-Clark (Boehringer Ingelheim)
Sarahann Simpson (Pfizer)
Karen Whitelock (Novartis)
Sreeja Sudhakaran (Consultant)
Stephanie Fripp (Johnson and Johnson)
Who should attend
This course is for professionals who are new to the pharmaceutical industry and need to understand the role of pharmacovigilance within the drug development process. It is anticipated that individuals from a variety of educational areas including, drug safety, regulatory affairs, medical information, quality assurance, and clinical research will benefit from attending this workshop.
Pharmacovigilance (PhV) in context
Risk/benefit safety profile of a product and the role of PhV
Key processes in a PhV system
PhV and key legislative framework
Key concepts, terms and definitions used in PhV
Management and reporting of AEs
Clinical trial environment o Post Authorization
Role of PhV in safety management of a product
By the end of this workshop delegates will be able to....
Discuss what pharmacovigilance is and how the modern day industry is shaped out of the events of the past
Discuss why current legislation for pharmacovigilance continually evolves
Outline how the risk benefit profile of a product develops and changes over the entire lifecycle of a product
Discuss the cross functional role of pharmacovigilance interfaces with internal and external stakeholders
Identify key processes of a pharmacovigilance system and the role it plays in minimising harm to patients
State the key Australian and foreign legislative framework for pharmacovigilance that informs the basis of company standard operating procedures
Locate relevant guidance documents for pharmacovigilance and apply them
Define key concepts, terms and definitions used in pharmacovigilance
State how adverse events are collected, documented, assessed, processed, reported and submitted to regulators in clinical trials
Discuss how data collected is used to update the safety reference documents
Identify all potential sources of adverse events both internally and externally
Outline the regulatory reporting requirements for spontaneous adverse events
Discuss how reports link into the risk benefit profile of the product and this leads to the update of the core datasheet and local product document
Discuss the role of pharmacovigilance in the proactive safety management of a product
Note: This workshop will focus on pharmaceuticals. Differences in reporting for medical devices, biologicals, and vaccines will be highlighted throughout the session.
This is an entry level/introductory course. There are no entry criteria for this workshop. If you have any questions on your suitability for this course, do not hesitate to call the ARCS Business Office on (02) 8905 0829.
Important Terms and Conditions
• ARCS Australia is committed to ensuring advertised educational events go ahead. Despite all our efforts, occasionally, some events will need to be postponed or cancelled due to lack of attendee numbers. This decision is made in conjunction with the event chairperson. Your early registration for events will assist us to assess the interest for this event in your state. We recommend for interstate travel that flexible travel arrangements are made until the event has been confirmed as ARCS Australia will not be held responsible for forfeited costs. With your support we are committed to delivering these events, so please submit your registration early.
• All delegates must pay the registration fee prior to attending training.
• ARCS member registration rates are not transferable to non-ARCS members. By selecting a member registration rate, it is agreed that the registrant is a current financial member of ARCS and that the registration is made in the ARCS member’s name (s) only.
• If a non-ARCS member attends an event as a substitute for an ARCS member, the difference in registration fees must be paid.
• No refunds, transfers or cancellations will be accepted within two weeks of an event.
• Cancellations and transfers more than two weeks from an event date will incur a 10% administration fee.
• ARCS Australia may need to amend the programme from time to time or due to circumstances beyond our control. Therefore, we reserve the right to make changes to the programme and/or facilitator without prior notice.
Course Fees (incl. GST)
Earlybird - Until 16 Febr
ARCS Member $556.00
Retired/Student Member $418.00
Non Member $751.00
Standard - From 17 Feb
ARCS Member $611.00
Retired/Student Member $459.00
Non Member $826.00