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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Get Your Design in Control

This webinar covers the key phases of design and development for medical devices. We cover all key terms and requirements identified in quality systems standards and regulations (e.g. ISO 13485, MDSAP, 21CFR820), share our experience and provide practical tips for the implementation of each phase into a quality management system.

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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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Medical Device Risk Management for Patient and Product Safety

This webinar explores how Risk Management is critical to the regulatory frameworks and provides an overview of the fundamental principles and key standards. In addition, it explores some best practices for implementing risk management activities within your organisation, including post-market considerations.

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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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Basic rules of pharmaceutical advertising in France

Are in you interested in knowing more about drug promotion in France? This webinar offers you a compact overview on how to promote a drug in France along with specifics and rules you need to be aware of. You will be introduced to a full spectrum of details: from the basic rules, to promotion for the public and for Healthcare Professionals (HCPs), as well as the so-called ‘visa’ rule (i.e. pre-approval system).

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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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US NDA versus EU MAA eCTDs – Exploiting the Synergies and Mastering the Differences

Initial authorization applications for new drugs and biologics in the US and Europe are among the most challenging tasks faced by Regulatory Operations. The applications typically include approximately 1,000 documents and hundreds of thousands of pages that need to be authored, reviewed, and published (usually under very tight timelines). While the harmonization brought to us with the eCTD format has certainly increased the efficiency of preparing multiple regional dossiers at once, differences in the required content and format between health authorities persists.

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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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What you need to know to submit Study Data to FDA & what the new FDA Technical Rejection Criteria means for you

What you need to know to submit Study Data to FDA & what the new FDA Technical Rejection Criteria means for you

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Central American Regulation for Drug Products (LATAM)

The RTCA is for the pharmaceutical industry covers several topics from the technical point of view like Analytical Method Validation, Good Manufacturing Practices, Labelling of Pharmaceutical Products, Quality Assurance, Stability Studies and Requirements for Marketing Authorizations.

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Unlocking BLA, NDA, IND Submissions Key considerations and LORENZ docuBridge training

The first part of this webinar will provide you with the theoretical background to plan, prepare and execute highly efficient and compliant eCTD sequences for the FDA. The second half of this webinar will feature a live demonstration of compiling submissions based on the BLA template using LORENZ docuBridge software.

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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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TGA (Australia) Approaches for Accelerated Medicine Approvals

This webinar presents the TGA’s recent application process changes and outlines how local and international pharma companies can leverage these pathways to truncate regulatory approval timelines in Australia, reduce the regulatory resource burden for supporting evaluations, and accelerate patient access.

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Marketing a drug in France, what are the responsibilities of an exploitant?

This webinar offers an overview of the exploitant status in France together with an overview of key French regulations in that matter. An exploitant is a pharmaceutical company based in France, having a “Pharmacien Responsable” and having been authorised by French Agency. Roles and responsibilities cover various activities, such as: promotion, pharmacovigilance, medical information, distribution, sales, batch recall, complaints, shortage …. Alternatively, companies may choose to market a drug in France from another European country (EU) as long as they comply with the French regulation.

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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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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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eCTD in China

The aim of this webinar is to present and analyze the new challenges for Pharmaceutical Industry that arise with the upcoming eCTD requirements in China. It will provide an overview on the Chinese technical requirements and interpretation of ICH eCTD rules, Module 1 and envelope particulars, complications resulting from overall language and translation needs, but also consequences for submission planning, coordination and the inclusion of Chinese eCTD publishing into an integrated global publishing environment.

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Electronic Submission in the EAEU - the challenges

The first part of this webinar will provide an overview and update on the new Regulatory legislation in the Eurasian Economic Union (EAEU) and its impact on pharmaceutical companies intending to apply for new or to preserve existing Marketing Authorisations in the Region. It will also explain the key features of the mandatory eCTD-like EAEU electronic submission format.

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Medical Device Software: Current Developments in the Regulatory World

This webinar presents fundamental regulatory considerations for Software which is in a Medical Device (SiMD) and stand-alone Software as a Medical Device (SaMD). It discusses the similarities and differences in the context of medical device regulations and provides examples for each.

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Streamline Operations with Unified RIM system

Join this webinar co-hosted by Veeva and Pharmalex to learn how a unified RIM solution can help companies streamline regulatory processes and make those partnerships more effective and powerful.

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The applicability of EU Codes to pharma activities and materials

This short webinar will be facilitated by Dr Rina Newton, who manages PharmaLex’s UK-based healthcare compliance and medical approval functions. With many pharma companies operating at EU above-country level, this webinar will review the applicability of different country codes to their outputs. We will discuss several proven ways to increase efficiencies in the approval of such activities and materials.

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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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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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Implementation of an efficient QRM program

Quality Risk Management has been a hot topic for many years in the Pharmaceutical Industry and appropriate management of risk in our processes and procedures has become the foundation on which Quality compliance is based. This webinar will discuss how to get the most benefit from a QRM program so that it delivers its full potential as a powerful tool for decision making, prioritisation, efficiency, continuous improvement, training and knowledge management.

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Marketing Cannabis in European Countries

Companies gaining market access for Medical Cannabis in Germany and other European countries are confronted with complex and differing national requirements. From cultivation to distribution of medical cannabis, all activities are legally linked to individual national laws under control of the individual European countries. The EU is missing a harmonized law on medical and recreational use of cannabis. This webinar gives a general overview on the legislation in different European countries reflecting different kind of programs for patient´s access to medicinal Cannabis.

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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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Risk Management of the presence of Nitrosamines in medicines

The presence of nitrosamines, potentially carcinogenic compounds, in some chemically synthesized drugs has led to the withdrawal and supply of several drugs from the market and has raised the alarm among regulatory agencies around the world, especially in Europe. As a result of these events, a new strategy for the control and monitoring of these compounds must be defined by the pharmaceutical laboratories.

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New legal requirements for electronic submissions in the EEU

The Eurasian Union (EAEU) is working to implement a submission process that is similar to the eCTD model and also other ICH guidelines. The new regulation affects all marketing authorization holders as well as all new drug applications. This webinar is a must-see for anyone who wants to stay up-to-date and implement the new requirements smoothly.

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Safety considerations for an Rx to OTC Switch Program

The OTC Drug Monograph identifies specific requirements for a class of drug products.  If product complies, manufacturer does not need FDA approval before marketing.  However new ingredients targeting are not developed OTC monograph process. These products made it to the market via a New Drug Application.  These drugs can arrive via OTC switch, of which there are 2 types:  a full or partial switch.

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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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Vendor Management Programs - Ensuring Success!

Vendor management is a challenge for bio/pharmaceutical companies throughout all phases of product lifecycle. Using effective vendor management tools can promote good working relationships, leading to favorable vendor performance and successful outcomes.

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Achieving and maintaining REG CMC Compliance

The complexity of Pharmaceutical operations makes Chemistry, Manufacturing and Control (CMC) compliance increasingly difficult to achieve and sustain. Often, CMC compliance programmes offer no more than a ‘snap-shot in time’ of compliance.  A strong RA / Quality partnership, however, supporting implementation of transformed systems/processes can provide a sustained compliance outcome.

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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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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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Emerging Markets: LATAM

The LATAM market is quickly becoming one of the leading pharma markets worldwide. This webinar will offer you an overview of what to keep in mind in order be prepared and potentially secure a leading position in this emerging market.

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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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EudraVigilance – The fundamental tool for Pharmacovigilance

In this complimentary webinar, PharmaLex experts discuss updates on the EudraVigilance database and shed light on the Electronic Reporting System. Learn how to download Individual Case Safety Reports (ICSRs) and understand the EudraVigilance data analysis system (EVDAS).

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ISO IDMP Implementation in Europe

With Organisations Management Services (OMS) as the initial part of EMA’s Substances, Products, Organisations & Referentials (SPOR) Master Data hub going live in 2017, industry has got its first flavour of how IDMP will impact regulatory processes in the future. This webinar will provide an overview on how IDMP will affect our way of working in Regulatory Affairs and beyond, and what industry should do now to ensure they are prepared.

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Brexit: An update on preparations for MA holders

PharmaLex experts will provide updates for our UK and International audiences answering queries on how, as a Marketing Authorisation Holder (MAH), you can prepare for Brexit. Following the outcome of the UK’s referendum on membership of the European Union, we have analysed the most feasible Brexit scenarios and what their impacts could be for the Pharmaceutical industry.

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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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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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Mergers & Acquisitions related activities - A RA perspective

Dr. Adam King has nearly 30 years of experience working in the Pharmaceutical industry, with over 18 years specializing in global Regulatory Affairs and Regulatory Consultancy.

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Manage your Temporary Authorization for Use (ATU) in France

Anne Grassin combines over 10 years of experience project and team management with emphasis on delivering solutions and services for the pharmaceutical industry.

Patrick Larcier has a wealth of experience focusing on the development of drugs and biologics, as well as Companion Diagnostic tests.

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A comprehensive approach to regulatory portfolio management

Dr. Constanze Burkhardt’s experience in Strategic Outsourcing and Program Management has enabled her to build a strong team environment in a matrix management setting with a high commitment to the drug development and LCM process.

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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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What you need to know to submit INDs in eCTD format

Adair Turner joined PharmaLex in April 2017 as Principal Consultant, Director Regulatory Operations, where she is responsible for electronic submission activities, regulatory information management and related topics in the US.

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Learn how to get the most out of FDA meetings

Andrew S. Verderame, MBA, RAC leads our US-based Regulatory staff providing FDA-specific guidance and consulting services.

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