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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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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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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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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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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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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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