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regulatory affairs

As we are now a couple of months in after the enforcement of GDPR, we ask Robin Kerbel, CEO and co-founder from Six Degrees Medical* what the impact on the pharma sector is and what may be the wider implications of the regulation changes… more

Opinion

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 more

Opinion

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. more

Opinion

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. more

Opinion

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… more

Opinion

Pooja Phogat, regulation and compliance expert at Kinapse, advises on the best approaches to balancing the risk of patient re-identification with the need for greater data utility. more

Opinion

As the General Data Protection Regulation (GDPR) take effect this month, Mark Stevens, managing director, Formpipe Life Science, looks at the key differences companies should be aware of and how they can attain compliance. more

Opinion

The European Medicines Agency (EMA) has accepted Sanofi’s regulatory submission for sotagliflozin, a potential treatment for type 1 diabetes, for review. more

News

Today (Friday 9 Feburary 2018) marks the precise point that we are a year away until the European Union Falsified Medicines Directive (EU FMD) comes into force. Here, we feature some expert opinions more

Opinion

In this article, NSF International goes into detail about what the potential ramifications of Brexit may be on the regulatory landscape in pharma. more

Opinion

Here, Dan Anslow, UK sales manager, Crest Solutions, shares some key tips and insights, learned through partnering with pharmaceutical manufacturers that have already successfully implemented solutions for serialisation, aggregation and Track & Trace more

Opinion

Here, Vikash Patel, senior regulatory specialist for ELC Group, gives us an update on the regulatory developments impacting the pharma industry as a result of Brexit. more

Opinion

One of the potential pitfalls when preparing a product launch is planning for GMP inspections. An upside of recent events, is worksharing, leading towards a more globalised market. In this article Vikash Patel, ELC Group tells us more... more

Opinion

The findings from the final section (part iii) of the CPhI Annual Report have been announced by event organisers UBM. more

Analysis

With the forthcoming regulatory changes set to come into force over the next couple of years in pharma, management practices will surely be tested. In this article, Tom Nichols, Quanticate, details some of the challenges the industry will face. more

Opinion

Master data management promises an efficient, definitive way to address the demands of the forthcoming ISO IDMP standards for product information recording. What is involved in practice though, and how can companies ensure the investment pays off? more

Opinion

Pharmacovigilance is a dynamic clinical and scientific discipline that has had an important impact on the public health environment. Madalina Huruba, ELC Group, goes into the history and the necessity of an effective pharmacovigilance system more

Opinion

In this instalment, we find out about the life, loves and career drivers of the new director of Regulatory Affairs and QP Services at Wasdell, Colin Newbould. more

Opinion

Bruno Speder, SGS Life Sciences, gives an overview of new EU regulation 536/2014, introduced to provide a single European submission and approval procedure for clinical trials, and discusses the effects it may have on early phase clinical trials more

Opinion

Dr Rajendra Wable, subject matter expert-medical writing and regulatory affairs at ‎Sciformix Corporation, discusses how marketing authorisation applications across Europe, Australia and other countries can be supported with non-clinical overviews more

Opinion