SAP S/4HANA Validation: A Streamlined Approach

The SAP S/4HANA Validation: A Streamlined Approach webinar will demonstrate how companies can meet regulatory requirements, shorten the overall time frame and reduce the burden on staff, while also ensuring ongoing compliance through the use of an SAP Validation Compliance Package.

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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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Critical Regulatory Paths to Value Inflection

The webinar is hosted by One Nucleus but was held in cooperation with PharmaLex. The webinar will discuss the ATMP sector, why it is exciting from a technical point of view, and what opportunities there are to utilize new and innovative regulatory pathways to get these medicinal products to market, whilst ensuring that the desire for innovation is balanced with the requirement for a robust commercial strategy.

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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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Critical Considerations for Mergers & Acquisitions - legal and regulatory overview on due diligence

2021 started with stellar news as Sanofi agreed to acquire British biotech Kymab for around $1.45 billion. It is a chequered flag for the start of this seasons M&A activity for Life Sciences companies. Great expectations? PharmaLex and VWV  ponder legal and regulatory solutions for supporting M&A deals, takeovers, business moves, leveraging, spin-outs, carve-outs and strategic partnerships.

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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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QbD – Analytical Quality by Design

This webinars aims at showing the different steps to smartly use all information gathered throughout the life-cycle of the analytical method and bioassay to ensure its fitness of purpose. Combining scientific knowledge with adequate statistical methodologies has a crucial role to play: such as design of experiments, statistical modeling, design space definitions and probabilistic statements.

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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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Eudravigilance: overcoming challenges and gaining efficiencies with SMARTVIGISCREEN

SMARTVIGISCREEN is a cloud-based software solution that processes incoming ICSRs automating the analysis of company vs non-company cases and taking away manual efforts. The tool is GxP validated system according to GAMP 5 guidelines and CFR Title 21 Part 11 compliant. Moreover, SMARTVIGISCREEN is fully validated for both EVW and MLM download process and can easily be integrated with ICSR Management process, generating up to 70% efficiency increase.

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Software Suite for the Life Cycle of Analytical Methods & Bioassays: Gain Trust in your Results

In this webinar three Software-as-a-Service (SaaS) solutions – Enoval, Seelva and Transval – will be presented, which meet current and newly developed regulations for two key steps in the lifecycle of analytical methods and bioassays: Validation and Transfers. All three solutions enable them to obtain fully compliant reports in minutes and implement the proposals of the USP 1210 chapter by using statistical tolerance intervals and total errors to determine whether the analytical methods are suitable for the purpose. At the end of the study, you will have more confidence in the analytical results obtained with them.

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Brexit – Preparing for the end of the transition period and beyond

PharmaLex experts will provide updates for our UK, EU and international audiences answering queries on the most recent updates and final preparations for the end of the Brexit transition period. Following recent intense negotiations, the EMA and MHRA have recently published revised guidance setting out their position on preparing for the end of the transition period.

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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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QbD and Process Characterization

Product quality is achieved through process validation. During process characterization, manufacturers are using Quality By Design tools in order to acquire knowledge on the process. In this webinar, process scientists will be introduced to important concepts that will ease their communication with statisticians.

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Virtual Audits Webinar

The webinar on Virtual Audits will present the current regulatory expectations, benefits and challenges of virtual auditing and will share expertise on the planning, preparation, performance and reporting for a virtual audit.

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Good Statistical Practices - Discovery to Clinical Research

For 15 years the scientific literature repeatedly underlines the important lack of reproducibility and replicability of studies in biomedical and psychological research. As a consequence, several scientific organizations (journal, scientific societies, universities, national agencies) have identified some root causes to this issue and proposed good research practices to improve the reproducibility of the results.

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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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An Overview to Non clinical testing: why? when? what?

Why is non-clinical testing needed? This webinar will deliver you an overview of the non-clinical framework in the EU. Furthermore different products are shown as examples to illustrate the process of non-clinical testing in praxis.

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Early-Phase Modelling – Costs and Effectiveness in Pharma

This webinar offers an overview of the benefits early-phase, health-economic modelling can provide, at a stage when the outcome of the product development program is still largely unknown. Early-Phase Modelling balances between accuracy and manageability, and represents an easy to grasp, conceptual overview of your product and its potentials regarding reimbursement.

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Strategy For A Successful Quality By Design Implementation

Bruno Boulanger holds a PhD in Experimental Psychology from the University of Liège (Belgium). Since 2000, Dr. Boulanger is Senior Lecturer at the Université of Liège, in the School of Pharmacy, teaching Design of Experiments and statistics. He organizes and contributes to Non-Clinical Statistics in Europe.

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