Victoria Goff
Victoria graduated from university with a BSc in Chemistry with analytical science and began working as a quality control operative for ProSynth Ltd. In 2006 Victoria commenced a new role at Mundipharma Research Limited in the analytical team within Product Development. In this role Victoria gained extensive experience of drug development along with skills in project management and generation of regulatory documentation for clinical trials (Phase I-III) and Module 3. In 2017 Victoria moved to the Regulatory CMC team within Mundipharma Research to a role that involved authoring, review and submission of Module 3 MAA/NDA for Europe, APAC and LATAM and associated query response activities. Victoria also gained significant experience leading submissions for post approval changes in Europe, APAC and LATAM. In 2019 Victoria joined Kinapse as a Senior Manager in Regulatory CMC supporting multiple clients in both pre and post approval activities. Victoria rejoined Mundipharma in 2021 as the Head of Regulatory CMC and in this role and is responsible for the team providing regulatory CMC strategy across all the portfolios to maintain global compliance and support commercial opportunities.
EditorialDiverse and dynamic regulation in the Asia Pacific region
Starting in Australia, authors David Batka and Kate Burke look at the trends within its market for 2024. Two years ago, the Australian government and its regulatory agency, the Therapeutic Goods Administration (TGA), initiated an expert review of medicine and device regulations to bring about reforms for patient access, flexible ...
JournalQ&A:
Navigating the
pharmaceutical supply chainMatthew Scripps, Director, Supply Chain Planning, Mundipharma interviewed by Vickie Goff, TOPRA Editorial Board member
EditorialThe worldwide web of regulation
In this issue, we focus on the pharmaceutical supply chain and the interaction of this function with regulatory. The supply chain team are the link between the manufacturer and the customer, and they are impacted by the complexity of regulations across different global markets and work with regulatory colleagues to ...
EditorialThe region walking the regulatory walk
Latin America (LATAM) is a large market with considerable promise for pharmaceutical growth, with a total potential patient population of more than 600 million people. The landscape in Latin America is changing quickly with demand growing as populations age and chronic diseases become commonplace.
EditorialRegulatory operations: Evolution and revolution
‘Operations’ does not quite do justice to the critical role that these individuals play in the global team
JournalUpdates to quality legislation from the EMA
Brian Dooley, Quality Specialist in the Pharmaceutical Quality Office of the EMA, discusses his role, new marketing applications and updates to quality legislation.
EditorialCMC acceleration is driven by a scientific revolution
The role of CMC technical and regulatory experts is essential for ensuring continuous innovation and successful regulatory approvals
FocusRegulating medicines in a surge of change
RegRap speaks to Steve Hoare, Quality Regulatory Science and Safety Policy Director at the ABPI
JournalSelection and justification of regulatory starting materials
A regulatory starting material (RSM) is the registered point at which drug substance manufacturing under good manufacturing practice (GMP) begins. RSMs are defined, isolated materials that are required to meet the general principles outlined in ICH Q11. This article provides guidance for small molecules in selecting and justifying starting materials from a risk-based perspective.
InterviewBuilding best regulatory practices in Brazil
Gustavo Mendes Lima Santos, General Manager of Medicines and Biological Products at ANVISA, explains how the agency has aligned with best practices of others across the world, and discusses important updates to legislation in Brazil.