In response to the government’s Home Affairs Committee’s report on policy options for the future migration from the European Economic Area, Dr Sarah Main, executive director of the Campaign for Science and Engineering (CaSE) gives us her thoughts
The US Food and Drug Administration (FDA) has issued a warning to consumers about criminals who are forging warning letters, as though they have been written by the agency, in efforts to target individuals who are trying to purchase medicines online
Data and analytics company, GlobalData, has revealed that recent survey findings from the European Medicines Agency (EMA) into Brexit preparedness of the pharma industry support its own conclusions on the matter.
In this online opinion piece, Mark Davison, head of operations in the EU for rfxcel, outlines everything marketing authorisation holders (MAHs) need to know and what is needed for a seamless serialisation process
In this online exclusive, Paul Brooks, executive director, Regulatory Affairs Professionals Society (RAPS), looks at the impact Brexit may have on the healthcare product regulatory space and how clarity is urgently needed.
Now we have just passed the six-month marker (1 July) until the European Medicines Agency (EMA) moves from its current location in London to Amsterdam, as a result of Brexit, we gauge industry response to this change…
In this article, John Johnson, vice president, Pharma Biotech, NSF International, looks at the revision to Annex 1 and the important questions steriles manufacturers and pharma suppliers should be asking themselves.
As the deadline approaches for companies to be compliant with the new legislation to apply serialisation codes to every applicable pack of product, Gill Wright, design & development director, Cirrus, asks if you are ready for FMD…
Here, Declan Maguire, operations director, Celtic Anglian Water & Alpheus Environmental, discusses how to future-proof in this increasingly strict area through outsourcing.
GlobalData has stated that according to its latest research immune-based gene therapy candidates should prevail in oncology, however, this novel approach is unchartered territory in oncology and will require new regulatory guidelines
The Association of the British Pharmaceutical Industry (ABPI) has released a thought piece looking at the UK’s increasing role in the fight against antimicrobial resistance (AMR).
Five years on from the adoption of the EU falsified medicines directive (2011/62/EU) and the challenge continues. Here, Vincenzo Salvatore, BonelliErede (Milan), looks at the reasoning behind the directive and potential next steps
