Software Medical Devices – Considerations for Regulatory Compliance Success

Digital Health worldwide has had a massive growth in recent years, including new technologies in the healthcare space for both consumers and healthcare practitioners, such as wearable technologies, health apps and connected medical devices.

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Bayesian Expert Prior Elicitation to Aid Decision Making in Biopharmaceutical Development

Expert knowledge is a valuable source of information to augment available data or when interpretation/synthesis of data requires expert judgement. Prior elicitation is a key tool for translating this expert knowledge and judgement into a quantitative probability distribution that can then be used in the design, analysis, and interpretation of clinical and observational studies.

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Bench to Bedside: The need for an Integrated Product Strategy

Bringing new drugs to the market is becoming increasingly challenging and complex with multiple perspectives to be considered such as non-clinical, regulatory, clinical, CMC, Market access, statistics and operations among many others. In this webinar, we will discuss key elements needed to design and execute a bench to bedside integrated development strategy to help navigate these challenges in an optimized manner that increases the probability of regulatory approval and commercial success while managing costs and critical timelines. Case studies and client experience will be presented.

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Bayesian Statistics: Model to predict recruitment and inform supply chain

The smooth running of patient enrolment is a key determinant of success for clinical trials. Yet many trials fail to complete on time due to delays in patient recruitment. Indeed, more than 80% of clinical trials do not reach recruitment targets on schedule (Huang et al., 2018). Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist.

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Gene therapy products: regulatory expectations and challenges for the industry

Gene Therapy products continue to advance as unique therapeutic tools, offering potential cures to several genetic diseases for which there are no or limited treatment options.
Regulatory guidance on gene therapy products evolves at the same time, supporting the developers in their journey from early research phase to pivotal clinical studies, and eventually marketing authorization.

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Bayesian Methods for Joint Longitudinal and Survival Data

Many clinical trials and other medical and reliability studies generate both longitudinal (repeated measurement) and survival (time to event) data. Many well-established methods exist for analyzing such data separately, but these may be inappropriate when the longitudinal variable is correlated with patient health status, hence the survival endpoint (as well as the possibility of study dropout).

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Remediation and Preparations: a recap of current state and what is next for Medical Devices and In Vitro Diagnostics in Europe under MDR and IVDR

During this session, the PharmaLex Medtech Expert, T.J. Thiel, will revisit the Medical Devices Directive (MDD, 93/42/EEC) and In Vitro Diagnostic Directive (IVDD, 98/79/EC) and their transitions to the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostic Regulation (IVDR, 2017/746), respectively.

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Healthcare system resilience during and after the pandemic

Pharmalex and Vintura have the pleasure to invite you to a discussion dedicated to healthcare system resilience during and after the pandemic from the perspective of Patient Access to innovation and optimal care.

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Bayesian Approaches for Incorporating Natural History Data in Studies of Rare and Pediatric Disease

In this webinar, after a very brief review of Bayesian adaptive clinical trial methods, we introduce our Bayesian responder approach to one-arm clinical trials in rare disease modeling, investigating the impact of both static and transient placebo effects.

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Orphan Drugs for Rare Diseases in Children – Considerations for PIPs and PSPs

The global clinical development of medicines for orphan diseases in pediatric patients is challenging for drug developers as different regulatory requirements were established in the EU and US for pediatric investigation plans (PIP) and pediatric study plans (PSP) for new products.

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Post-Brexit 2021 Health and Life Science Sector Impact – Legal and Regulatory Overview

Arthur Cox (legal) then PharmaLex (Regulatory) experts will provide respective updates for UK, EU, and international webinar delegates. There will be the chance for Q&A on the most recent updates and ongoing preparations for future post-Brexit developments. There is published guidance from lawmakers and regulators, setting out their positions and rules. However, there are also gaps where expert interpretation is best taken, not only for long-term compliance but to also get ahead.

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Excipient Risk Assessment as per the EU Guidance and SMARTRISK as a solution

This webinar will discuss the key points in the performance of a compliant excipient risk assessment and how the PharmaLex tool, SMARTRISK, can help provide a solution for Marketing Authorization Holders that need support with the management of Excipient risk.

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Bayesian Adaptive Approaches in Rare and Pediatric Disease

In this webinar, after a very brief review of the Bayesian approach, we illustrate its use in simple data combination methods, including traditional two-step approaches, as well as ones using power priors, commensurate priors, and robust mixture priors for incorporating sensibly downweighed versions of the auxiliary information.

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Introduction to Bayesian Methodologies in CMC

Chemistry, manufacturing, and control (CMC) is a crucial stage in drug development. In CMC, activities such as defining product characteristics and modeling manufacturing processes are carried out to ensure the safety, consistency, and efficiency of drug products. In this webinar, we will demonstrate the importance of applying Bayesian statistics to CMC via several case studies.

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An Update to In Vitro Diagnostics Regulatory Requirements Worldwide

This webinar presents a summary of the common terminology when identifying IVDs, including in-house, stand-alone, point-of-care, self-testing and Companion Diagnostic IVDs. For each of these different IVDs, there is generally different classification for all regulatory agencies.

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Biotech Drug Development Challenges and Case Studies (CMC)

This talk provides an overview of biotech drug development and focusses in the most common CMC pitfalls we have recently observed and how to avoid them.

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Bayesian Power, Assurance and Probability of Success

In this webinar you will learn the important difference between probability and certainty in order to successfully implement a clinical trial. The more uncertainties you include in your clinical trial, the better you can assess your chances in the follow-up. In this webinar, you will learn important details about how to make your clinical trial a success, together with our two experts Maud Hennion and Arnaud Monseur.

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Medical Device Clinical Evaluation Reports (CERs) -What you need to know

The webinar presents on four key aspects of CERs: Clinical Trials, demonstration of equivalence, literature reviews and analysis of post-market data. These are critical components of Clinical Evidence Reports, and those which are often misunderstood by authors. The webinar explores what these aspects mean for Clinical Evidence Reports and how they can be applied, delving deeper into key parameters and considerations.

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ClinPHLEX |Strategic & Cross-Functional Partnership

ClinPhlex is a global, cross-functional, clinically-focused team that works in close collaboration with a client to  provide innovative, customized, efficient, strategic and tactical solutions to optimize and de-risk development. Our expertise and global experience in clinical development, clinical-regulatory strategy, biostatistics and biostatistical regulatory strategy, clinical and translational pharmacology as well as clinical research/operations and program management allow ClinPhlex to evaluate and improve your current position.

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Overview of the biotech drug development pathway

This webinar offers an overview of the multidisciplinary (CMC, non-clinical and clinical) requirements for the development of biotech products, outlines the regulations, highlights critical requirements and summarizes common CMC pitfalls and how to avoid them.

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Environmental Risk Assessments for Human Medicinal Products

Dr. Angela Vogt-Eisele, Senior Manager Scientific Affairs, Pharmalex will give you a clear overview on Environmental Risk Assessments for Human Medicinal Products especially about Challenges and Recent Developments.

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Regulatory Landscape for Tissue, Cell and Gene Therapy

Dr. Buljovcic is a Biologist and has 15 years of experience working in the Regulatory Affairs business, including 10 years specializing in Tissue, Cell and Gene therapies.

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Optimize your biosimilar development strategy

Zeb Younes has over 16 years´ of experience in biopharmaceutical / biosimilar development lifecycle from proof of concept through to, and beyond commercialization with both laboratory and desk based experience in process development, purification, formulation, method development, characterisation, validation, comparability, release and stability testing.

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