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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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