SAP S/4HANA Validation: A Streamlined Approach

The SAP S/4HANA Validation: A Streamlined Approach webinar will demonstrate how companies can meet regulatory requirements, shorten the overall time frame and reduce the burden on staff, while also ensuring ongoing compliance through the use of an SAP Validation Compliance Package.

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Get Your Design in Control

This webinar covers the key phases of design and development for medical devices. We cover all key terms and requirements identified in quality systems standards and regulations (e.g. ISO 13485, MDSAP, 21CFR820), share our experience and provide practical tips for the implementation of each phase into a quality management system.

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Medical Device Risk Management for Patient and Product Safety

This webinar explores how Risk Management is critical to the regulatory frameworks and provides an overview of the fundamental principles and key standards. In addition, it explores some best practices for implementing risk management activities within your organisation, including post-market considerations.

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Orphan Drugs for Rare Diseases in Children – Considerations for PIPs and PSPs

The global clinical development of medicines for orphan diseases in pediatric patients is challenging for drug developers as different regulatory requirements were established in the EU and US for pediatric investigation plans (PIP) and pediatric study plans (PSP) for new products.

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Critical Regulatory Paths to Value Inflection

The webinar is hosted by One Nucleus but was held in cooperation with PharmaLex. The webinar will discuss the ATMP sector, why it is exciting from a technical point of view, and what opportunities there are to utilize new and innovative regulatory pathways to get these medicinal products to market, whilst ensuring that the desire for innovation is balanced with the requirement for a robust commercial strategy.

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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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US NDA versus EU MAA eCTDs – Exploiting the Synergies and Mastering the Differences

Initial authorization applications for new drugs and biologics in the US and Europe are among the most challenging tasks faced by Regulatory Operations. The applications typically include approximately 1,000 documents and hundreds of thousands of pages that need to be authored, reviewed, and published (usually under very tight timelines). While the harmonization brought to us with the eCTD format has certainly increased the efficiency of preparing multiple regional dossiers at once, differences in the required content and format between health authorities persists.

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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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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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Brexit – Preparing for the end of the transition period and beyond

PharmaLex experts will provide updates for our UK, EU and international audiences answering queries on the most recent updates and final preparations for the end of the Brexit transition period. Following recent intense negotiations, the EMA and MHRA have recently published revised guidance setting out their position on preparing for the end of the transition period.

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TGA (Australia) Approaches for Accelerated Medicine Approvals

This webinar presents the TGA’s recent application process changes and outlines how local and international pharma companies can leverage these pathways to truncate regulatory approval timelines in Australia, reduce the regulatory resource burden for supporting evaluations, and accelerate patient access.

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An Update to In Vitro Diagnostics Regulatory Requirements Worldwide

This webinar presents a summary of the common terminology when identifying IVDs, including in-house, stand-alone, point-of-care, self-testing and Companion Diagnostic IVDs. For each of these different IVDs, there is generally different classification for all regulatory agencies.

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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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Medical Device Software: Current Developments in the Regulatory World

This webinar presents fundamental regulatory considerations for Software which is in a Medical Device (SiMD) and stand-alone Software as a Medical Device (SaMD). It discusses the similarities and differences in the context of medical device regulations and provides examples for each.

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Streamline Operations with Unified RIM system

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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Marketing 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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New legal requirements for electronic submissions in the EEU

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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Achieving and maintaining REG 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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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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ISO IDMP Implementation in Europe

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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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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