B04a. Preparing an effective listed medicines efficacy package
Tracks
Prescription & Non-prescription Medicines Regulation
| Wednesday, June 4, 2025 |
| 11:15 AM - 12:15 PM |
| Parkside 1 |
Chair & Speakers
Amne Alrifai
Director
Avicenna Consulting
B04a. Preparing an effective listed medicines efficacy package
Abstract
The Australian marketplace for listed medicines operates within a robust regulatory framework overseen by the TGA. Sponsors must ensure that their products meet legislative requirements, including providing evidence to substantiate claims made for the product's efficacy.
Developing a comprehensive efficacy package is critical for regulatory compliance and consumer confidence - but not everyone does it right. In 2022/23, only 29% of listed medicines that were subjected to a compliance review by the TGA were compliant (TGA Performance Report 2022-23).
This presentation will provide a practical roadmap for preparing an effective efficacy package for listed medicines. We will discuss the regulatory obligations which sponsors have to hold suitable evidence. We will then provide key insights regarding:
1. Designing a search strategy: how to systematically identify relevant evidence using credible sources.
2. Selecting suitable studies: key considerations for evaluating study quality, relevance, and population applicability.
3. Addressing conflicting evidence: strategies for critically assessing and managing discrepancies in literature
4. Summarising and justifying evidence: Best practices for structuring a cohesive narrative that clearly links evidence to claims.
5. Avoiding common pitfalls: insights into frequent errors that are likely to cause issues if the product is subject to a TGA compliance review.
Attendees will gain an understanding of how to balance scientific rigour with the practicalities of a fast-paced regulatory environment where everyone is striving to sell their product. By the end of the session, participants will be equipped with the knowledge and tools to develop robust efficacy packages that stand up to regulatory scrutiny, support compliant marketing, and ultimately enhance consumer trust in listed medicines.
Developing a comprehensive efficacy package is critical for regulatory compliance and consumer confidence - but not everyone does it right. In 2022/23, only 29% of listed medicines that were subjected to a compliance review by the TGA were compliant (TGA Performance Report 2022-23).
This presentation will provide a practical roadmap for preparing an effective efficacy package for listed medicines. We will discuss the regulatory obligations which sponsors have to hold suitable evidence. We will then provide key insights regarding:
1. Designing a search strategy: how to systematically identify relevant evidence using credible sources.
2. Selecting suitable studies: key considerations for evaluating study quality, relevance, and population applicability.
3. Addressing conflicting evidence: strategies for critically assessing and managing discrepancies in literature
4. Summarising and justifying evidence: Best practices for structuring a cohesive narrative that clearly links evidence to claims.
5. Avoiding common pitfalls: insights into frequent errors that are likely to cause issues if the product is subject to a TGA compliance review.
Attendees will gain an understanding of how to balance scientific rigour with the practicalities of a fast-paced regulatory environment where everyone is striving to sell their product. By the end of the session, participants will be equipped with the knowledge and tools to develop robust efficacy packages that stand up to regulatory scrutiny, support compliant marketing, and ultimately enhance consumer trust in listed medicines.
Biography
Amne is an expert on the regulatory frameworks governing public and environmental health. She holds a Juris Doctor and Bachelor of Medical Science, bringing together technical and regulatory skills to support government and private projects. She has years of experience in driving large regulatory and operations projects at the federal and territory level, amending and creating legislation and providing guidance in the public and environmental health space, approving new therapeutic goods, undertaking post-market reviews of listed therapeutic products, and providing strategic advice to businesses supplying health products in Australia.
As Director of Avicenna Consulting, Amne provides support to those wishing to introduce new listed medicines substances, therapeutic goods, foods, cosmetics, and other health products to the Australian market. This includes negotiation with regulators, review and preparation of evidence packages, and supporting companies undergoing post-market review of these goods.
