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regulatory affairs

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

Dr Prashanth BSB, head of safety and medical writing for ELC Group, talks to EPM about the ramifications Brexit may have on the pharmacovigilance landscape. more

Opinion

As pharma anticipates the forthcoming Brexit negotiations and future uncertainty, Stephie Castling, senior marketing executive from Denny Bros, examines the regulatory concerns coming to the fore in the industry. more

Opinion

Lonza has revealed it has gained all regulatory approvals for its proposed acquisition of Capsugel, which the company anticipates will close over the next few days subject to the satisfaction of customary closing conditions. more

News

Narasimharaju SN, senior manager — regulatory affairs and Mac Kella, senior regulatory affairs executive at ELC Group assess whether biosimilars are really interchangeable in the EU. more

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In this article, Mark Usher of Solidsoft Reply, explains the challenges of deploying multiple connected national systems for the large-scale European pharmaceutical industry. more

Opinion

Lini Subin, director — regulatory affairs, ELC Group, highlights EMA’s regulatory tools and support pathways that are available during development. more

Opinion

Camargo Pharmaceutical Services has appointed Marc Wiles, Ph.D., as vice president, scientific and regulatory affairs, and Suzanne Beck, J.D., M.P.H., as director, contracts and legal projects. more

News