Latest Trends on Global Registrations for Pharmaceutical Products: An Australian Case Study

Friday, January 17, 2020
8:30 am – 11:30 am

Location:

BDO
3570 Carmel Mountain Road, Suite 400
San Diego, CA 92130

Sponsored By:

If your company is planning clinical trials for pharmaceutical products, then this workshop will provide valuable insights for your clinical strategy.  The workshop will provide an update on the latest programs being developed and piloted by regulators the Australian Government expedite approvals for Pharmaceutical products. The program will also cover best practices for global clinical trials, and how to leverage the incentives in Australia to expedite and accelerate market access globally.

The program will cover:

• Case studies on parallel reviews (including regulator feedback)
• How to leverage Australian approvals to gain approval in other APAC territories
• How to lay the foundations, and special considerations that should be addressed early-on in order to execute global regulatory approvals and participate on these types of programs.

Background:

Historically, most major global regulators have undertaken a de-novo comprehensive evaluation of pharmaceutical applications regardless of whether they have been reviewed and approved by other major regulators, leading to duplication of efforts and delays to patient access.

During this presentation we will outline the recent programs pilots in Australia to truncate the evaluation activities and timelines through the recognition of product evaluations and approvals by comparable international regulators. These programs are being piloted between the EU, Canada, FDA and Australia.

The utilization of this approach can accelerate companies to market access in these key geographies and as an extension to expand to broader regions.

The success of these programs may open a new paradigm for international registration of pharmaceutical products. 

Objectives:

• Describe the opportunity to obtain a simplified regulatory evaluation and an accelerated regulatory approval by leveraging approvals in the other regulated markets (USA, EU, Canada, Australia).
• Outline new regulatory approval pathways for international registrations using Australia as a case study.
• Outline best practices on how to leverage clinical data for international registrations.
• Identify how regulatory approvals in Australia can serve as a steppingstone to regulatory approvals in the Asia Pacific region.

Agenda:

8:30 – 9:00am: Networking and light breakfast

9:00 – 10:30am: Presentations

10:30 – 11:00am: Discussion & Q & A

11:00 – 11:30am: Networking

Speakers

Robert Stringer, Director of Pharma Services, Brandwood CKC

Robert Stringer has more than 25 years of experience in the Australian and New Zealand pharmaceutical industry.

Prior to establishing Capital K Consulting, Robert was a member of the leadership team at AstraZeneca Australia, having managed the Regulatory Affairs, Clinical Research and Strategic Planning & Business Development teams. His career also includes the green fields market entry into Australia of Sandoz (the generic arm of Novartis), ultimately holding the role of Research and Development Manager. In this role his responsibilities included leading the regulatory, product development, and quality assurance functions, along with joint leadership of the product sourcing and partnering arrangements. At Sandoz, Robert achieved the world-first market approval of a biosimilar.

Grant Bennett, CEO, Brandwood CKC

Grant Bennett has a deep and practical experience of regulatory affairs gained through medical devices industry roles across the Asia Pacific. His prior experience includes roles as Regional Regulatory Affairs Manager Asia Pacific and Australia/New Zealand Quality Assurance Manager with a US-headquartered, multinational supplier of professional Medical Devices.

An internationally respected industry leader, Grant chairs both the Regulatory Affairs Expert Panel and National Advisory Council for Australian industry peak body AusMedtech. He is an adviser to the Asian Harmonization Working Party (AHWP), supporting regulatory guidance development in pre-market assessments, labelling and UDI implementation