||ARCS Training Room - Suite 802, 28 Clarke Street, Crows Nest NSW 2065|
Updated in 2016 to include biological medicines!
This is hands on, practical two-day workshop provides a comprehensive overview of the regulatory requirements for Module 3: Quality and Module 2.3: Quality Overall Summary for chemical entities and biological medicines. It will be evaluation focussed, looking in-depth at the quality requirements and involving a detailed discussion of what evaluators look for. The workshop will provide:
* Background, content and detail of Module 3 data requirements for chemical entities and biological medicines;
* Advice on how to avoid some common deficiencies encountered by the TGA during evaluation of drug substance and drug product sections for chemical entities and biological medicines;
* Insight into rationale behind the data requirements for quality variations;
* Information on conducting risk assessments for medicines that contain, or are manufactured, using human or animal origin materials.
* An opportunity to interact with TGA PCS evaluators in a workshop environment.
Who should attend:
Regulatory affairs professionals who have limited to intermediate experience with Module 3: Quality and Module 2.3: QOS. Those who wish to increase their understanding of the content of Module 3 and how the data provided is utilised in the evaluation of regulatory applications.
* Prescription medicines submission and evaluation processes including the subtle differences in evaluation approach for chemical entities and biological medicines.
* CPMP/ICH Guidelines relevant to Module 3:
- CTD structure
- Module 3.2.S
- Module 3.2.P
- Module 2.3
* Other Quality Guidelines and references
* Overview of minor variations process and data requirements through workshopped examples.
* TGA presentations and workshop facilitation
At the end of the two days attendees should:
* Understand the data requirements of Module 3 and 2.3 and the differences between these for chemical entities and biological medicines.
* Understand the process of assembling Module 3 in consultation with the manufacturer and the guidelines
* Understand the Module 3 review process and identify deficiencies in consultation with the guidelines
* Understand the data requirements for different variations (SAR and Cat 3), referencing the minor variations guidelines for both chemical entities and biological medicines.
* Be able to better consider the perspective of the evaluator, both when preparing applications and reviewing requests for information.
Attendees should have attended “Introduction to Australian Regulatory Affairs” and/or have equivalent experience and familiarisation with the basic requirements of Module 3: Quality and Module 2.3: QOS as defined by the guidelines.
Workshop fees (incl. GST):
Early bird - until 03 Mar
ARCS Member - $898.00
Retired/Student Member - $674.00
Non Member - $1214.00
Standard - from 04 Mar
ARCS Member - $990.00
Retired/Student Member - $745.00
Non Member - $1337.00