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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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WatchIntroduction 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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WatchQbD 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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WatchBiotech 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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WatchBayesian 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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WatchElectronic Submission in the EAEU - technical and regulatory 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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WatchVirtual Audits
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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WatchImplementation 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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WatchGood Statistical Practices to Tackle the lack of Reproducibility from 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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WatchRisk Management of the presence of Nitrosamines in medicines: Regulatory expectations
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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WatchSafety 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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WatchClinPHLEX – A Strategically-Focused, Cross-Functional, Clinical Development 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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WatchAn 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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WatchVendor 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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WatchEarly-Phase Modelling – Estimating the Costs and Effectiveness of a Pharmaceutical before Clinical Trial Data is available
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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WatchOverview 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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WatchEnvironmental Risk Assessments for Human Medicinal Products – Challenges and Recent Developments
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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WatchEudraVigilance – 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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WatchBrexit: 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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WatchData Science: 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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WatchUnderstanding the Regulatory Landscape for Tissue, Cell and Gene Therapy Development
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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WatchMergers & Acquisitions (M&A) related activities - A Regulatory Affairs 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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WatchStrategic Outsourcing – 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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WatchOptimize 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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