Whitepapers

ICH Q13 Continuous Manufacturing: Shaping the Future of Pharmaceutical Production

Admin — Wed, 20 Aug 2025 10:12:35 GMT

Discover how continuous manufacturing is reshaping the life sciences industry—boosting efficiency, improving product quality, and aligning with modern regulatory expectations like Quality by Design (QbD).

PK/PD Modelling as a Strategic Driver for Pediatric Development Plans

Admin — Wed, 20 Aug 2025 10:12:35 GMT

Designing a Pediatric Development Plan (PIP/PSP) that satisfies regulatory requirements while remaining agile and cost-effective is one of the most complex challenges in drug development today. This is especially true in competitive therapeutic areas such as weight management, where speed to market is critical.

The Journey to Digital Transformation in Life Sciences

Admin — Wed, 20 Aug 2025 10:12:35 GMT

Introduction

When the Covid-19 pandemic struck the world, the importance of digital technologies in every aspect of life became incontrovertible. Every industry and individual had to shift their communications to digital platforms. Supply chain disruption forced global industries to adopt technologies to improve visibility, collaboration, and agility. In the life sciences and healthcare industries, the pandemic forced companies and countries to accelerate implementation of digital technologies – from telemedicine, to virtual clinical trials, to the imperative to share more data faster and in a harmonised way for innovation and to support public health. According to a GlobalData survey, 35% of pharmaceutical professionals say the pandemic sped up the digital transformation by more than five years. To better understand how the achievements to date have been possible – and how far we still have to travel – it’s important to assess how we got to this point in digitalisation. The origins of the journey towards digital transformation can be traced back more than 50 years and across multiple industries. From sharable and structured databases, supported by industry standardisation to the emergence of technology solutions such as EDMS and ECM to support large sets of documents and data in electronic format, the world of information storage, sharing, and traceability had been revolutionised in a short period of time.

Bridging the Gap: The Vital Role of Clinical & Translational Science in Advancing Cancer Research

Admin — Wed, 20 Aug 2025 10:12:35 GMT

The impact of regulatory pathways on anticancer drugs market access: how regulatory procedures shorten clinical development time

Learn about how expedited regulatory approval programs offered by the EMA and FDA can significantly reduce the Clinical Development time for new anti-cancer drugs. Our latest article dives into the correlation between clinical development time and regulatory approval programs and how PLG's expertise in understanding the market landscape can save both time and cost to bring new anti-cancer therapies to patients.

Nitrosamines: a real health concern

Admin — Wed, 20 Aug 2025 10:12:35 GMT

In recent years, the primary concern for human safety has arisen from the presence of nitrosamines found in variety of products spanning pharmaceuticals, cosmetics, foods and food supplements. Nitrosamines are organic chemical substances that form under specific conditions when a nitrosating agent reacts with amino-based substances. The term "nitrosamine" describes a class of compounds with a chemical structure of a nitroso group bonded to an amine (R1N(-R2)-N=O). The International Agency for Research on Cancer (IARC) classifies these reaction products as probable human carcinogens due to their highly mutagenic and genotoxic potential, as evidence in several animal studies.

Revolutionizing Drug Safety: The Impact of Automation and Artificial Intelligence in Pharmacovigilance

Admin — Wed, 20 Aug 2025 10:12:35 GMT

Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. With exponential growth in data volume and complexity, traditional PV methods are inadequate. By adopting a multifaceted approach and applying the latest technological advancements, the PV process can be challenged. Automation and Artificial Intelligence (AI) offer the transformative potential to enhance PV activities' efficiency, accuracy, and comprehensiveness.

Artificial Intelligence (AI) in Pharmacovigilance: do we really need it…?

Admin — Wed, 20 Aug 2025 10:12:35 GMT

A EUCROF (EUropean CRO Federation) article co-written by Marco Anelli, MD - Senior Medical Advisor at ProductLife Group, Milano

There seems to be a lack of clarity about the meaning of terms such as “artificial intelligence (AI)”, “machine learning (ML)”, “data science (DS)” and “office automation (OA)”, which should not be used interchangeably. Pharmacovigilance (PV) represents a very interesting field in this regard, since it poses some unique technical challenges. For example, the “signal to noise ratio” and the “quality of the information” are very different in reports from clinical trials and in information coming from social networks, smartphone apps or smartwatches, and therefore require different approaches. Case processing, moreover, requires a mix of administrative and repetitive tasks (e.g. data cleaning and form filling) and tasks that require a high level of experience and specialization (e.g. medical reviews and signal detection). Technology now offers a wide spectrum of solutions, which go from already available “simple” procedure automation allowing significant improvements in efficiency and quality to sophisticated Natural Language Processing (NLP) solutions, which have shown interesting results but are not yet fully operational. A sensible approach, from the perspective of a PV executive, could be to start implementing and reaping the benefits of already available solutions while at the same time keeping the landscape monitored for new developments. In the second part we will address some of the open issues, of organizational, social and regulatory relevance, concerning the implementation of AI- and ML-based technologies in our domain.

White paper: ProductLife Group Highlights the Key Role of Artificial Intelligence (AI) in Transforming the Life Sciences Industry

Admin — Wed, 20 Aug 2025 10:12:35 GMT

ProductLife Group (PLG), a global leader in consulting and outsourcing services for the Life Sciences industry, announces the release of its latest report titled "An Introduction to the Transformative Power of AI in Shaping the Pharmaceutical Industry." The pharmaceutical sector is undergoing unprecedented technological acceleration, largely driven by artificial intelligence (AI). This report explores how AI is already transforming key areas such as regulatory affairs, manufacturing, pharmacovigilance, and market access, as well as its potential for the future of R&D. Technologies like machine learning and generative AI are already in play, speeding up drug discovery, regulatory dossier preparation, and safety data monitoring. However, challenges remain, particularly in terms of data management, adoption of this new technology by teams and development of business models that justify investments in AI.