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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