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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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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