PharmaLex Talks

In this episode of the PharmaLex Talks Podcast, sits down with Alex Brenchat, Vice President of Local Affiliate Pharmacovigilance Services at PharmaLex, a Cencora company. Together, they explore the complexities of pharmacovigilance (PV) in a global context, focusing on the unique challenges faced by local affiliates in navigating diverse regulations post-marketing. With over 20 years of experi...

Join Angela-Vogt Eisele, Associate Director Scientific Affairs at PharmaLex, a Cencora company for this podcast, where she shares her expertise in Environmental Risk Assessment and its growing importance in the German Pharma Strategy

Join PharmaLex's Patrick Nieuwenhuizen for this podcast, where he shares his expertise in sterility assurance and how manufacturers can demonstrate that the finished product is sterile through a holistic contamination control strategy (CCS), based on a risk assessment.

Pharmaceutical companies new to the EU market must navigate complex and varying commercialization requirements. The podcast highlights key steps for commercialization readiness in Europe, focusing on the challenges non-EU companies face, including supply chain logistics and regulatory complexities. Early planning, strategic partnerships, and understanding local regulations are essential for suc...

Louise Uí Fhatharta bio Quality professional with over 20 years’ experience in Microbiology, Quality Control and Quality Assurance roles in the Pharmaceutical Industry including Sterile Fill Finish and Medical Device. Involved in site and laboratory expansion projects from design through to method transfer and operational readiness. Supported site in a capacity of Quality, Sterility Assurance ...

A contamination control strategy (CCS) is integral to Annex 1 and is fundamentally about patient safety and identifying and avoiding contamination pathways. Manufacturers are expected to implement a CCS across their facilities in order to define all critical control points and assess the effectiveness of all the controls and monitoring measures employed to manage risks associated with contamina...

Synopsis: In this podcast, Gerardo Gomez talks about the interactions between validation and technology transfer, considering the views and expectations of the regulators. As Gerardo explains, technology transfer is really a very sophisticated and complex project management activity and therefore needs to be carefully planned to avoid discrepancies or deviations from the regulations. Bio: Dr. ...

Synopsis: Early access programs are designed to allow patients suffering from a life-threatening unmet medical need or disease to be given promising treatments that have not yet received marketing approval. Examples of these types of programs include named patient programs, which are for a specific patient suffering from a rare, ultra-rare or life-threatening disease, and cohort programs, where...

Bio Patrick Nieuwenhuizen Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Fill Finish and Solid Oral Dose. Involved with several site and laboratory expansion projects from con...

Synopsis: Technology transfer involves two main types: scale-up and transfer to a different site. Scale-up technology transfer involves moving a technology or process from a laboratory or pilot-scale environment to a larger production scale. Transfer to a different site involves relocating a technology or process from one location or organization to another. Listen to the podcast to learn more ...

Bio: Michael Braun-Boghos Michael has been working in medicinal product safety for the last three decades. He spent 13 years at the European PV headquarters of Fujisawa, which later became Astellas, ultimately leading the Safety Data and Quality Management group. Thereafter he joined Relsys, the developer of the Argus software, and finally came to Oracle with the Relsys acquisition in 2009. As...

Market access can be a big hurdle for companies to overcome and might require a different approach to the process of gathering evidence to support reimbursement discussions. Early phase modeling can help to inform feasibility of future adoption, the product development program, support investor communication, and sometimes even to inform decisions on whether to pursue product development or not...

Combination products offer unique advantages in terms of delivering improved therapeutic outcomes or enhanced patient convenience. Typically, combination products are understood to be a drug-device or biologic-device combination. The regulatory strategy as to which center at the FDA has jurisdiction over product approval depends on their primary mode of action. Listen to the podcast to learn mo...

Companies often fall into common traps in early-stage product development. These range from interactions with the regulators to their ability to manufacture their product. Forward planning is crucial, but all too often smaller companies lack the regulatory, business development or marketing expertise needed to support this way of thinking. The podcast explores some of the pitfalls companies can...

The pharmaceutical industry has been globalizing for many years as demand for medicinal products grows and as companies look to expand into the large and increasingly prosperous emerging markets. The impact of rapid globalization is that the industry is dealing with complex and ever-changing regulations and government policies that can vary across jurisdictions. The podcast explores the opportu...

For US-based companies seeking to market their product in the EU, it can be a struggle to navigate a different market, and, in particular, to manage requirements from a safety reporting perspective. The podcast explores the challenges faced managing not only the European pharmacovigilance legislation but also dealing with each EU Member State, which can implement these requirements in their own...

Artificial intelligence is playing an increasingly important role in document management in the life sciences industry and in particular in improving management and oversight of the Trial Master File (TMF). The podcast explores why and how AI is a gamechanger for the TMF and what it means for pharmaceutical companies now and in the future. Bio: Jim Horstmann is Product Manager of Clinical Prod...

Summary: IVD manufacturers must perform two types of performance studies, clinical performance and analytical performance, in order to provide evidence that the device is safe and performs as intended. While both have always been required, IVDR is a lot more prescriptive. Speaker: Keely So is Manager, Medical Devices / IVD at PharmaLex, leveraging her extensive knowledge of the regulatory requ...

Summary: A lot of statistical work within pharmaceutical companies is repetitive and this costs money and resources, especially if it’s done within GxP environments where there is often a need for double programming, extensive data quality control and meticulous follow-up of procedures. The podcast explores requirements and ways  to  develop fully automated solutions and processes to address th...

A strong quality culture in the biopharmaceutical industry is one in which all participants in the organization understand patient safety and how their roles impact patient safety risks. It is one where decisions are prioritized based on patient safety first. From a GMP perspective, that means not only abiding by the formal law but knowing the applicable current best practices, understanding th...

There are unique considerations and nuances to the US Food and Drug Administration’s (FDA) pre-submission process for medical devices that companies need to consider. Known as the Q-submission (Q-sub) program, these pathways are a way of communicating with the regulator to obtain their feedback on particular topics that are germane to both the manufacturer and the regulator. About the speaker:...

With pharmaceutical companies increasingly turning to outsourcing partners to support maintenance of marketed products, efficiency and reliability are imperative. Digitalization, in particular automation and AI, plays an integral role in streamlining processes and enhancing that outsourcing relationship. Timm Pauli is Vice President and head of R&D informatics at PharmaLex, where he combines h...

This podcast introduces the concept of strategic product development as part of an integrated strategy to bring new drugs to the patients that need them. This holistic approach helps to save time, reduce overall development costs, and identify and mitigate risk throughout the product lifecycle.

Introduction: The ICH-Q2 and ICH-Q14 together describe the development and validation activities proposed during the life cycle of an analytical method to assess the quality of medicinal products. But what is it that defines the quality of a reportable value? The podcast explores how Bayesian statistics makes it possible to take an observation made during the validation of the analytical proced...

Brad Carlin is a statistical researcher, methodologist, consultant, and instructor.  He currently serves as Senior Advisor for Data Science and Statistics at PharmaLex, an international pharmaceutical consulting firm.  Prior to this, he spent 27 years on the faculty of the Division of Biostatistics at the University of Minnesota School of Public Health, serving as division head for 7 of those y...

Under the Medical Devices Regulation economic operators – that is manufacturers, the authorised representative, importers and distributors – all face new roles and obligations. While some of these responsibilities existed under the Medical Devices Directive, workload will be impacted. From requirements around Eudamed, to having a person responsible for regulatory compliance, to ensuring certain...

The next frontier in outsourcing is the management of established marketed products, which provide the opportunity to sustain revenue, keep maintenance costs low and ensure compliance of mature products.

A recent survey of senior pharmaceutical and biotech executives explores why IPD programs are becoming an increasingly important strategy to successfully bring a new drug to market.  To find out more, we speak with Frédéric Pailloux, Senior Director, Head of Integrated Product Development & Consulting, at PharmaLex.

Classification and regulation around medical device software has become more complex, and in recent years most regulatory authorities have tightened the regulatory pathways. The podcast explores software differences and how these impact regulator classifications in various markets. It also looks at key considerations for managing the oversight of these products, in particular with regards to a ...

Some major changes have been outlined in the EU Annex 1 Revision. Listen to PharmaLex expert Patrick Nieuwenhuizen on how the industry can implement the new Annex 1.

IVDR Brings Huge Change to Manufacturers Distributing Products in Europe The In Vitro Diagnostic Regulation (IVDR) means enormous upheaval for companies, as now up to 90% of products will need to be reviewed by a notified body before they are eligible for distribution in Europe under the IVDR. That’s a huge about-turn from the situation under the In Vitro Diagnostic Directive (IVDD), where app...

Jean has extended experience in all phases of the product lifecycle, driving compliance from concept initiation through to commercialisation and post-market support.  He provides Regulatory and Quality Assurance expertise to a broad range of companies from start-ups to multinationals and supports projects involving various medical technologies. He is bilingual in French and English and holds a ...

This episode of PharmaLex Talks features Bruno Boulanger, Senior Director, Global Head Statistics and Data Science at PharmaLex and an award-wining author on Global Statistics and Data Science (link https://www.pharmalex.com/bookauthority-announce-the-winner-of-the-best-new-bayesian-statistics-books-best-new-biostatistics-books-and-best-statistics-ebooks-of-all-time/).  Bruno´s visionary appro...

Industry experts on ATMPs discuss the challenges and regulatory landscape with respect to the development of ATMPs, and what support and guidance is available from regulatory agencies.

Meeting the regulatory challenges of the post-Brexit pharma landscape In the inaugural PharmaLex Talks podcast, host Elizabeth Hunt (https://www.linkedin.com/in/elizabeth-hunt-6194b630/) chats with Charley Maxwell (https://www.linkedin.com/in/charleymaxwell/) , Director QMC / Senior Consultant at Pharmalex about the post-Brexit Pharma landscape.  Their wide-ranging conversation covers many ke...