Julie Warner
Julie has been involved in regulatory affairs since 2003, gaining significant pre- and post-authorisation experience in disease areas ranging from oncology to cardiovascular and infectious diseases. She has a special interest in advanced therapies, orphan drugs, oncology, clinical trials and marketing authorisations.
EditorialThe increasing complexity of biological medicinal products
The world of biologics is shifting rapidly. In the more than 40 years since the introduction of the first biosynthetic human insulin in 1982, advances in scientific understanding and biotechnology have occurred at breakneck speed. This has resulted in the development of hugely novel products with the potential to give ...
EditorialMind the gap:
Innovation vs
regulation of ATMPsTechnology has always developed faster than regulation – but the pace at which science is advancing is not being matched by progress of the current regulatory framework which, in stark contrast, is consultative, slow, and regional.
EditorialWaltzing into change in Vienna:
The regulatory future comes into focusIt is the most wonderful time of the year – yes, that is Symposium issue time – and the Regulatory Rapporteur editorial team never want to disappoint! The TOPRA Symposium is one of the major annual events for those working in regulatory affairs, and the 2022 Symposium – hosted in ...
EditorialRegulatory operations: Evolution and revolution
‘Operations’ does not quite do justice to the critical role that these individuals play in the global team
EditorialHow regulators are navigating the evolving pharmacovigilance landscape
In the area of regulatory affairs and pharmacovigilance (PV), we are constantly confronted with new laws, guidelines and other regulations