Progress towards the EAEU legislation has been slow over the past year as the regulatory authorities in the five countries — Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan – work towards harmonisation. While the process of adapting to a single market can be frustrating for companies, the time involved is understandable. Building the EAEU and common The post Five Years to a Single Market: Why Building the EAEU is a Huge Task appeared first on ProductLife Group ..read more

As I mentioned in my last blog, one of the challenges with addressing medicinal shortages is that the approach is national, rather than EU-wide. Efforts are being made to address this inconsistency, however, there is still no adequate European legislation to deal with shortages, just a guideline on the detection and notification of medicinal product The post Finding EU-wide Solutions to Drug Shortages appeared first on ProductLife Group ..read more

Between now and 2025, regulators and life sciences companies will have much to do to prepare for the Eurasian Economic Union (EAEU) legislation. There are many benefits to establishing the EAEU, which brings together Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan, but becoming a single market requires much work and negotiation. Let’s look first at what The post Gearing up for 2025: What to Expect with EAEU Legislation appeared first on ProductLife Group ..read more

As I stated in the first in this blog series, COVID-19 has been a catalyst for more rigorous debate about the topic of drug shortages. During the DIA panel discussion — “Coordinated European Approach to Solve the Problem of Shortages – Is It Possible?” – speakers discussed the causes of shortages, various approaches to address The post What does product shortage really mean? appeared first on ProductLife Group ..read more

Much is said about outsourcing in the life sciences, but for many businesses insourcing has long been an effective way to manage through peaks and troughs while retaining control of processes. Given that outsourcing has grown in strength and reliability, why then would companies continue to seek to insource talent? Depending on the types of The post An Expert with Team Knowledge: The Ins and Outs of Insourcing appeared first on ProductLife Group ..read more

Drug shortages have long been a problem for countries worldwide and one that the European Medicines Agency has been seeking to address. In 2016, EMA and the Heads of Medicines Agencies (HMA) set up a taskforce to look into the issue and to assess why authorised medicines are not available. During the DIA Europe 2020, The post Unravelling the reasons for drug shortages appeared first on ProductLife Group ..read more

Across the world, there is an enormous push to develop products to counter and treat COVID-19. Thousands of clinical trials are taking place, investigating hundreds of potential products. If there is one thing the pandemic has taught the life sciences industry it is that partnership and collaboration are vital in the rush to bring life-saving The post Partners in trials: Collaboration the key to bringing products to market to treat COVID-19 appeared first on ProductLife Group ..read more

Since the effects of COVID-19 will remain with us for a long time to come, ProductLife Group is actively supporting research into new drugs targeting the virus, among other practical measures, as part of our contribution to reducing the risk to human life. This is our duty both as a responsible organisation operating within local The post Doing our Bit to Progress COVID-19 Research appeared first on ProductLife Group ..read more

Cross-Functional Team Addresses Italian Client’s Needs The post Case Study: Affiliate Pharmacovigilance and Regulatory Affairs Support for SciClone appeared first on ProductLife Group ..read more

After three years of uncertainty, Brexit is now a reality. In the end, the announcement on 31 January 2020 that the UK had ended its membership of the EU was not a surprise. What was unexpected, however, was the decision by the MHRA to withdraw its guidance and publications about a possible no-deal Brexit. After The post Withdrawal of MHRA Guidance Means Business-as-Usual for the Short Term appeared first on ProductLife Group ..read more