News & Events

Medicine shortages are becoming an increasingly important challenge for pharmaceutical companies across the EU, with potential consequences for continuity of supply, regulatory compliance and, most importantly, patient care. Supply chain vulnerabilities, manufacturing and quality issues, unexpected changes in demand or limited alternatives can all contribute to disruptions that may ultimately affect medicine availability. For Marketing… View Article …

Veterinary pharmacovigilance can quickly become resource-intensive as companies work to maintain continuous oversight of veterinary product safety. Marketing authorisation holders must ensure appropriate pharmacovigilance expertise and keep their systems compliant, even when internal teams are already stretched or specialist veterinary PV resources are limited. For companies that need additional expertise or capacity, a large CRO… View Article …

Pharmaceutical Medical Affairs teams are expected to deliver scientifically credible, relevant and compliant education while managing increasingly complex evidence, diverse healthcare professional needs and multiple communication channels. At the same time, limited internal capacity and demanding timelines can make it difficult to translate scientific objectives into consistent, high-quality educational programmes, making the right medical education… View Article …

Understanding the patient journey from the first symptoms to diagnosis, treatment, and long-term disease management is essential for pharmaceutical companies developing truly patient-centric strategies. Yet patient journey barriers are rarely uniform. Diagnostic delays, referral gaps, limited treatment access, fragmented care, adherence challenges, and unmet information needs can occur at very different stages depending on the… View Article …

Veterinary pharmaceutical companies operate in an environment where maintaining product safety requires continuous oversight and specialised expertise. Effective veterinary pharmacovigilance requires marketing authorisation holders to maintain appropriate pharmacovigilance systems, continuously monitor product safety, manage safety information, maintain relevant documentation, and ensure that regulatory responsibilities are fulfilled throughout the lifecycle of veterinary medicinal products. As portfolios… View Article …

Bringing a pharmaceutical product to market requires far more than generating strong scientific data. Companies must navigate complex regulatory requirements, coordinate documentation across multiple functions, meet strict submission timelines, respond to health authority questions, and maintain compliance after approval. Without the right regulatory oversight, even relatively small gaps can lead to incomplete submissions, additional authority… View Article …

Preparing a regulatory submission involves much more than compiling documents into the correct structure. Successful eCTD publishing requires precise dossier assembly, technically compliant XML backbones, accurate life cycle operations, and a thorough understanding of regional regulatory requirements. As regulatory authorities continue to advance electronic submission standards and the industry prepares for broader adoption of eCTD… View Article …

Every pharmaceutical company collects enormous amounts of data. Electronic health records, claims databases, patient support programs, Medical Affairs activities, market research, and real-world evidence all generate valuable insights every day. Yet despite this wealth of information, many organizations still struggle to answer fundamental questions: Why are patients diagnosed too late? Where do they discontinue treatment?… View Article …

Developing a successful payer strategy has become far more complex than demonstrating clinical efficacy alone. Today’s reimbursement decisions increasingly depend on whether pharmaceutical companies can clearly demonstrate real-world value, address unmet needs, and show how their therapy improves outcomes across the entire care pathway. An effective payer strategy should be built around real-world patient experiences… View Article …

Bringing a medicinal product to market requires far more than demonstrating quality, safety, and efficacy. Companies must also demonstrate that the product is unlikely to pose an unacceptable risk to the environment. An incomplete or poorly prepared Environmental Risk Assessment (ERA) can lead to regulatory questions, additional data requests, prolonged review timelines, and unnecessary costs…. View Article …

The introduction of the new EU Veterinary GMP framework represents a significant regulatory change for manufacturers of veterinary medicinal products. Since 16 July 2026, dedicated Good Manufacturing Practice (GMP) requirements for veterinary medicinal products and veterinary active substances have applied under Commission Implementing Regulations (EU) 2025/2091 and (EU) 2025/2154, adopted pursuant to Regulation (EU) 2019/6…. View Article …

The pharmaceutical industry is entering one of the most significant changes in product information management in decades. While the traditional package leaflet remains a regulatory requirement, companies are now preparing for the gradual introduction of the electronic leaflet through the European Medicines Agency’s electronic product information (ePI) initiative. This transition is now anchored in the… View Article …

Keeping veterinary medicines safe after they reach the market is not simply a regulatory expectation—it is an ongoing responsibility. Under EU veterinary pharmacovigilance legislation, marketing authorisation holders (MAHs) must continuously monitor the safety of their products, identify emerging risks, and take appropriate action whenever new safety concerns arise. At the centre of this process is… View Article …

Despite major advances in cancer diagnosis and treatment, many oncology patients still experience fragmented care, delayed diagnoses, limited access to therapies, inconsistent education, and challenging transitions between healthcare providers. Every delay, communication gap, or missed intervention can negatively affect treatment outcomes, patient experience, and adherence. For pharmaceutical companies, these challenges also make it more difficult… View Article …

Modern veterinary safety case management is no longer just an operational pharmacovigilance activity—it is a business-critical function that directly affects regulatory compliance, product safety, and market confidence. As veterinary pharmaceutical companies expand into new markets, manage growing product portfolios, and navigate increasingly complex regulatory requirements, the volume and complexity of adverse event reports continue to… View Article …

Pharmaceutical companies invest significant time and resources into medical education, yet many Medical Affairs teams struggle to achieve the impact they expect. Working with large global providers can mean lengthy approval processes, generic educational programmes, limited flexibility, and reduced access to senior scientific experts. As project complexity increases, these challenges can delay delivery, place additional… View Article …

The expectations placed on pharmaceutical companies to deliver high-quality, scientifically accurate, and compliant medical education have never been higher. Healthcare professionals expect relevant, evidence-based educational content, while regulators require that all scientific communication remains balanced, accurate, and aligned with applicable standards. At the same time, Medical Affairs teams are often expected to deliver increasingly complex educational programmes with limited internal resources,… View Article …

Pharmaceutical companies today face increasing pressure to maintain continuous oversight of product safety while meeting ever-evolving global regulatory expectations. A robust signal detection process in pharmacovigilance is no longer limited to reviewing individual case reports—it requires the ability to identify, validate, assess, and act on emerging safety signals using data from multiple sources throughout the… View Article …