GXP Compliance Australia® was established in 2023 by Dr Kasia Hoffler.
Qualifications
International
- 1998 – Medical Doctor (MBBS), Silesian Medical University (Poland)
- 2003 – GCP Clinical Research Associate (Europe)
- 2008 – GCP Accreditation (Singapore)
- 2010 – GCP Auditor (Singapore, Malaysia, Indonesia, Thailand, Taiwan, Philippines, South Korea, Vietnam)
Domestic
- 2013 – Deputy Qualified Person Responsible for Pharmacovigilance in Australia
- 2019 – Pharmacovigilance Inspector, TGA
- 2019 – Certificate IV in Government Investigation, Regulatory Compliance
- 2020 – Integrated Governance, Risk Management and Compliance
- 2020 – Diploma in Audit
- 2022 – GCP Inspector, TGA
Who is Kasia Hoffler?
I am a curious student of life. The curiosity led me to wear many hats.
Hat 1: Medical Doctor
As a physician in Europe, I discovered that many of my patients could benefit from available treatments, but others could not, including my loved ones. This realization inspired me to discover the world of clinical research.
Hat 2: Clinical Research Associate
As a clinical research professional, I was privileged to be a part of many clinical trials. The first trial was a double-blind phase 3b study of rotigotine patches trialed in patients with Parkinson’s disease. I monitored investigator sites, managing clinical trial participants. The trial results proved efficacy and safety of the treatment. I remember the initial regulatory submission package, consisting of endless volumes of paper-based records, the size of an entire study room. It took an incredible effort of the sites, sponsor and CRO to put the package together. The treatment was approved by multiple regulators around the world and served many patients with PD.
Hat 3: GCP Auditor
As a clinical QA Auditor in Asia, while executing the GCP Audit Programs for a range of clinical trial sponsors and auditing numerous investigator sites, I witnessed the heroic efforts of the researchers and sponsors to prove the efficacy and safety of new treatments, targeting cancer. I saw many lost battles, and some precious moments of victory. During this period, I discovered that only the top-quality data generated by the site can be used for scientific and regulatory purposes. Even the most promising efficacy data could be considered invalid if collected or documented in breach of the applicable regulations and guidelines.
Hat 4: Pharmacovigilance Officer
As a drug safety professional in Australia, working as a Deputy Qualified Person Responsible for Pharmacovigilance (QPPV), I discovered the world of safety, spanning from the first-in-human-clinical trial, through the stage of authorisation, marketing and supply, up to the end of life and discontinuation or withdrawal from the market. It opened my eyes to the key role of ongoing safety monitoring and risk management of the medicines. I witnessed the most innovative and efficient treatments taken out of the market for safety reasons. I understood the role of the vigilant systems that warn us early and allow us to better manage risk of medicines. I was grateful to be a part of the journey of many patients, who suffered adverse reactions to new and old medicines. Listening to their stories was an eye opener. I discovered that patient experience navigates pharma companies in managing use of medicine, including indications, contraindications, warnings, precautions and dosing regimen. Moreover, I saw how patient experience influenced drug regulator in making significant regulatory decisions relating to the use of medicines. It led me to the next professional destination: the Australian drug regulator.
Hat 5: Regulatory Inspector
As a regulatory inspector, I had an incredible honour to work with some of the best regulatory science professionals in Australia. I learnt from the first Pharmacovigilance and GCP Inspectors, who established the Australian Pharmacovigilance and GCP Inspection Programs. While inspecting a range of Pharmacovigilance systems and a number of investigator sites conducting clinical trials in Australia, I saw a variety of approaches to quality and compliance. I was inspired by the expertise and commitment of the regulated sector, aiming to deliver safe treatments to patients in Australia and beyond. Some companies established sophisticated quality systems with an agile approach, constantly adjusting to ever changing environment. Some others were still in discovery mode, trying to define what quality and compliance meant for them.
Hat 6: Independent GXP Compliance Auditor
In 2023 I decided to put a new hat on. As an independent GxP Auditor at the GXP Compliance Australia®, I am putting my hand up to support businesses and organisations who perceive quality as a journey, not a destination. By fostering the culture of quality and compliance, I would like to contribute to the efforts of all domestic stakeholders, including pharmaceutical and biotechnology companies, academia, healthcare professionals, regulatory authorities, government commissions, industry bodies and other organisations. We all have a common goal to deliver safe and efficient treatments to our patients and maintain the strong position of Australia on the map of drug discovery.
