Original presentation date: June 2020

Overview 

This webinar will outline the regulatory environment for medicine and the basic processes for registration in Australia and New Zealand. It will also present the available expedited pathways and will also compare and contrast the two countries.

Learning objectives

From this webinar, you will:

• Gain an overview on the regulatory environment in Australia and New Zealand
• Understand the basic process for registration in Australia and New Zealand
• Understand the differences in regulatory processes
• Learn about expedited pathways in the two regions

Target audience

Regulatory affairs professionals with 2-5 years' experience who are interested in the current processes and updates for Australia and New Zealand. Professional who want to build on their general regulatory knowledge of major submissions and strategies for expedited pathways.

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 paid for 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.