Early-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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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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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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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 – 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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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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The challenges of achieving and maintaining Regulatory 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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ISO IDMP Implementation in Europe – how SPOR will change the Regulatory Environment

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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Environmental 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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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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Data 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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Understanding 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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Strategic 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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Mergers & 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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How will you 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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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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