B03. Bumps along the clinical trial journey: dealing with challenges in obtaining ethics / governance approval and problems that may impact a clinical trial
Tracks
Clinical & Regulation
Wednesday, June 4, 2025 |
11:15 AM - 12:15 PM |
Parkside 2 |
Chair & Speakers
Lachlan Porter
Consultant
CLINICO
Bumps along the clinical trial journey: dealing with challenges in obtaining ethics / governance approval and problems that may impact a clinical trial
Abstract
This session will explore the myriad challenges and issues that can arise before, during or after a clinical trial, and the practical and legal options that may need to be considered in response, including:
• best practice in liaising with HRECs and RGOs, including streamlining ethics and governance applications;
• subsequent complications with obtaining and retaining ethics and governance approval, particularly in long term studies;
• ownership of clinical trial data;
• disputes with service providers; and
• issues in recruiting participants.
• best practice in liaising with HRECs and RGOs, including streamlining ethics and governance applications;
• subsequent complications with obtaining and retaining ethics and governance approval, particularly in long term studies;
• ownership of clinical trial data;
• disputes with service providers; and
• issues in recruiting participants.
Biography
Ms Claire Finfer
Research Development Manager, Ethics And Governance
Northern Sydney Local Health District
Bumps along the clinical trial journey: dealing with challenges in obtaining ethics / governance approval and problems that may impact a clinical trial
Abstract
This session will explore the myriad challenges and issues that can arise before, during or after a clinical trial, and the practical and legal options that may need to be considered in response, including:
• best practice in liaising with HRECs and RGOs, including streamlining ethics and governance applications;
• subsequent complications with obtaining and retaining ethics and governance approval, particularly in long term studies;
• ownership of clinical trial data;
• disputes with service providers; and
• issues in recruiting participants.
• best practice in liaising with HRECs and RGOs, including streamlining ethics and governance applications;
• subsequent complications with obtaining and retaining ethics and governance approval, particularly in long term studies;
• ownership of clinical trial data;
• disputes with service providers; and
• issues in recruiting participants.
Biography
Jonathan Kelp
Partner
MinterEllison
B03: Bumps along the clinical trial journey: dealing with challenges in obtaining ethics / governance approval and problems that may impact a clinical trial
Abstract
This session will explore the myriad challenges and issues that can arise before, during or after a clinical trial, and the practical and legal options that may need to be considered in response, including:
• best practice in liaising with HRECs and RGOs, including streamlining ethics and governance applications;
• subsequent complications with obtaining and retaining ethics and governance approval, particularly in long term studies;
• ownership of clinical trial data;
• disputes with service providers; and
• issues in recruiting participants.
• best practice in liaising with HRECs and RGOs, including streamlining ethics and governance applications;
• subsequent complications with obtaining and retaining ethics and governance approval, particularly in long term studies;
• ownership of clinical trial data;
• disputes with service providers; and
• issues in recruiting participants.
Biography
Jonathan specialises in complex and strategically significant intellectual property and technology disputes, with a particular focus on the life sciences and healthcare sectors. He advises clients on regulatory issues and disputes, including therapeutic goods approval, advertising, promotion, and reimbursement of medicines and medical devices. He successfully acted for Hospira and Pfizer in a novel administrative law challenge in the AAT concerning the first biosimilar product to be listed on the PBS following changes to the regulatory and reimbursement regime for biosimilars in Australia, following a section 60 appeal lodged by a third party. He has advised on a number of other novel and nuanced regulatory issues for pharmaceutical and medical device clients.
With over 20 years of experience, Jonathan has also represented clients in High Court, Federal Court, and Supreme Court litigation involving breach of contract, copyright, patents, trade marks, misuse of confidential information, misleading and deceptive conduct, and breach of director’s duties. He also advises private and public sector clients on strategies for protecting and enforcing their IP rights.
