The New German Coalition Agreement - Life Sciences Part

On November 24, 2021, the new German coalition presented its coalition agreement and plan for the next four years. The agreement was approved by the respective party committees and signed by the party leaders on December 7, 2021. The plan outlines a wide range of reforms for the healthcare and life science sector, but the following sections will have the greatest effect on biopharmaceutical companies.

Performing Literature Searches to Meet Vigilance Requirements

As the Good pharmacovigilance practices (GVP) module VI states “medical literature is a significant source of information” for marketing authorization holders and has to be taken into consideration. Marketing authorization holders are expected to perform international and local literature searches to identify pharmacovigilance (PV) cases and to detect safety signals to establish a product’s benefit-risk profile. ProductLife Group can help with all these activities.

The Role of Regulatory Affairs Professionals in Tackling COVID-19 Related Product Shortages

After 2 years, the Covid-19 pandemic continues to bring uncertainty and challenges. However, pharmaceutical, medical and scientific bodies are working hard to provide solutions.

While the development of vaccines has been a milestone in the fight against the virus, increasing public awareness about the importance of correctly using medicinal products continues to be a priority for healthcare and pharma professionals. During the ‘Omicron’ wave in January, AIFA, the Italian Drugs Agency, flagged the importance of correctly using antibiotics during a time where Italy is currently facing a supply shortage of azithromycin, an antibiotic often prescribed for the treatment of Covid-19.

How PLG’s Insourcing Model Help Support Clients

ProductLife Group provides a broad range of services, but we know that it is not just our specialist knowledge that makes our projects successful. The way that we provide support is often just as important, and as such we offer different working models depending on our clients’ needs. For many, a traditional outsourcing approach is an effective and efficient way to provide well defined support and specific deliverables. However, in some instances a different model is more appropriate. Insourcing involves integrating PLG’s experts into a company’s processes in a longer-term partnership.

A Successful Major Variation Approval

Amidst the pandemic, the supply of a critical active pharmaceutical ingredient (API) threatened the availability of a one-of-a-kind product distributed in Spain. A complex biologic drug for the treatment of cardiac issues in hospital patients that required a specific API from a source in China. However, the pandemic led to supply chain issues which affected this API. With reducing stock levels, a lack of alternatives, and difficulty finding another manufacturer, there was growing concern about the potential impact on patients. In response to this urgent situation, our team at ProductLife Group (PLG) assisted in the submission of a Type II variation application to health authorities so that a new API manufacturer could be registered, ensuring the drug supply.

Transforming the conduct of clinical trials in the EU (ACT EU)

Prior to recent changes, all countries within the European Union (EU) were characterised by different healthcare systems resulting in varied regulations, timelines, styles of working, and criteria needed for conducting clinical trials. With the noticeable lack of cohesion between countries, and further challenges brought by the pandemic that reduced trial activity in the EU, a ground-breaking initiative known as ‘Accelerating Clinical Trials in the EU’ (ACT EU) has been introduced. It will transform healthcare across Europe and ensure the continuing development of safe and valuable medicines.

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February 2022 Monthly Newsletter