B26. Nitrosamine Impurities in Medicine - A Hot Topic

Tracks
Prescription Medicines Regulation
Thursday, June 13, 2024
4:30 PM - 5:30 PM
Pyrmont Theatre

Chair & Speakers

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Piety Rocha
Director Head of Regulatory Affairs and VDC Country Head
Cencora PharmaLex

Chair: Nitrosamine Impurities in Medicine - A Hot Topic

Biography

Piety Rocha is the Director, Head of Regulatory Affairs & Country VDC Head at Pharmalex, Australia. She has more than 20 years of experience in the Australian and New Zealand pharmaceutical industry. Piety is a seasoned regulatory affairs professional with a proven track record of delivering successful outcomes for complex and challenging projects. Piety has extensive knowledge and expertise covering innovative and generic prescription medicines across multiple therapeutic areas. Piety’s strengths lie in leading and managing a team of regulatory affairs specialists and providing strategic guidance and support to a diverse portfolio of clients, including generics manufacturers, innovators, and biosimilars developers. Piety is passionate about delivering regulatory excellence and ensuring patient access to safe and effective medicines.
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Diego Martinez
Associate Director, Regulatory Affairs
Cencora PharmaLex

Nitrosamine Impurities in Medicine - A Hot Topic

Biography

With more than 10 years of experience in the Pharmaceutical industry, Diego joined Pharmalex as Senior Manager for the Spanish team. Before that, he held a position as Head of Pharmaceutical Development in Cyndea Pharma. Previous to this position, Diego worked in Laboratorios Cinfa, in Pharmaceutical Development department. Diego received his diplomas in Biochemistry and Biology in University of Salamanca, Spain as well as Master Degree in Analytical Chemistry. His professional career gives him global vision and better understanding of the whole lifecycle of a pharmaceutical product and a deep knowledge in GxPs, pharmaceutical development, manufacturing processes, analytical methodologies and clinical parts. This background allows him to perform a comprehensive evaluation of the dossier including early CMC, as well as to propose the most appropriate regulatory strategies. After 5 years as Senior Manager, he was promoted to Associate Director, this new role allows him to lead the cross functional teams supporting transformation programs in Innovation, lead the strategy and vision for the products in this area (CMC & Quality), in collaboration with the senior leaders across all therapeutic and cross functional teams involved in development. He is able to identify and solve both strategic issues and provide recommendations at health leadership level across R&D. Lead the cross-functional delivery teams, across multiple agile teams and set clear strategic direction by clarifying priorities and rational. Responsible for stimulating conceptual thinking and creativity across the team and challenging the status quo for continuous improvement.
Helen Hughes
Senior Evaluator, Pharmaceutical Chemistry Registration Section, Scientific Evaluation Branch
Department of Health and Aged Care (TGA)

Nitrosamine Impurities in Medicine - A Hot Topic

Biography

Dr Helen Hughes is a Senior Evaluator in the Pharmaceutical Chemistry Registration Section of the Therapeutic Good Administration. She is presently the TGA’s Quality representative member of the Nitrosamines International Technical Working Group (NITWG). has spent most of her career working in medicines regulation in evaluation, secretariat and public service management roles. Helen has held evaluator roles in both registration and variations across multiple streams, and positions in Scheduling and Committee governance and Experimental Drugs. Helen has a PhD in Chemical and Biomolecular Engineering from The University of Melbourne and completed her undergraduate with joint majors in Chemistry and Biology as well as Honours in Chemistry at The University of Wollongong.
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