Streamline Operations with Unified Regulatory Information Management

Join this webinar co-hosted by Veeva and Pharmalex to learn how a unified RIM solution can help companies streamline regulatory processes and make those partnerships more effective and powerful.

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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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eCTD in China

The aim of this webinar is to present and analyze the new challenges for Pharmaceutical Industry that arise with the upcoming eCTD requirements in China. It will provide an overview on the Chinese technical requirements and interpretation of ICH eCTD rules, Module 1 and envelope particulars, complications resulting from overall language and translation needs, but also consequences for submission planning, coordination and the inclusion of Chinese eCTD publishing into an integrated global publishing environment.

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Cannabis – Spotlights on legal basis and regulatory requirements for marketing of Cannabis in European Countries

Companies gaining market access for Medical Cannabis in Germany and other European countries are confronted with complex and differing national requirements. From cultivation to distribution of medical cannabis, all activities are legally linked to individual national laws under control of the individual European countries. The EU is missing a harmonized law on medical and recreational use of cannabis. This webinar gives a general overview on the legislation in different European countries reflecting different kind of programs for patient´s access to medicinal Cannabis.

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The EAEU electronic Submission Challenge – New legal requirements for electronic submissions in the Eurasian Economic Union

The Eurasian Union (EAEU) is working to implement a submission process that is similar to the eCTD model and also other ICH guidelines. The new regulation affects all marketing authorization holders as well as all new drug applications. This webinar is a must-see for anyone who wants to stay up-to-date and implement the new requirements smoothly.

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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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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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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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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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