Original presentation date: 22 February 2021 

Overview

This webinar will clarify the regulatory requirements for the approval of clinical trials of small molecules in Australia and New Zealand, which are the basis for the speed and simplicity of clinical trial approval in these countries, and make them such an attractive location for early phase trials (in particular).

This complements our previous webinar on ‘The Regulatory Environment in Australia and New Zealand’.

Learning objectives

• Appreciate both the general country environment and the regulatory environment
• Understand the context for clinical trial (CT) review and approval in Australia and New Zealand
• Learn about the basic CT processes 
• Look at other means to supply unapproved medicines

Target audience

• This webinar is suitable for those with between 2-5 years experience. 

Presenter 

Jennifer Svec
Regulatory Consultant 

After completing a PhD in Pharmacology at the University of Melbourne, Jennifer started working in the pharmaceutical industry in regulatory affairs in 1987.  This gives her more than 33 years in regulatory affairs, and the industry, including work in big pharma (until 2004) and as a freelance consultant now for more than 15 years. most of her work has focused on prescription medicines (with a short period in generics) and mainly in submissions and strategies supporting clinical-based regulatory submissions (from CTN and CTX applications, NCE/NBE submissions, clinical variations - extensions of indications, orphan drug designations and literature based submissions). 

In addition to developing and delivering in-house training for clients, Jennifer has also acted as global regulatory lead for several early development products.  As a result of working in the industry for over 30 years Jennifer has established professional relationships with staff at both TGA and Medsafe and maintains a wide network within the Australian industry, collaborating closely with other freelance consultants in areas including clinical research, toxicology evaluation and pharmacoeconomics, as well as regulatory affairs.  Jennifer is part of the Working team for the TOPRA CRED Orphan drugs Program.

CPD

This course offers 1 CPD hour for successful completion, to learn about why CPD is important visit the Lifelong Learning page.

Price 

Members: £70+VAT

Non-members: £95+VAT

Access

Once you have purchased the webinar, you will receive an email from topclass@topra.org with a link to the webinar within one hour. Once received, simply click on the link in the email to access the webinar. You will have access to the webinar for six months from the day of purchase. Please note, if you select the pay later option, you will not have access until payment has been cleared.

Terms and conditions

Please read the training terms and conditions before booking this webinar. By booking this webinar, you are agreeing to the terms and conditions.