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Leverage PK data in PharmaPendium to inform drug development strategies

Pharmacokinetic information from FDA and EMA regulatory documents informs translational and clinical development decisions and may lead to more successful drug development and regulatory approval strategies.

In this webinar, we will discuss how to leverage comparative pharmacokinetic information from FDA and EMA Drug Approval documents to make better-informed decisions on which drugs have the most potential to succeed in clinical development.
Recorded Mar 27 2018 48 mins
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Presented by
Sherry Winter, PhD
Presentation preview: Leverage PK data in PharmaPendium to inform drug development strategies

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  • Systematic searching with Emtree May 23 2018 2:00 pm UTC 60 mins
    Embase Customer Care Representative: Dr. Josephine Zimmermann
    Embase wouldn’t be Embase without Emtree, the life science thesaurus is a hierarchically structured, controlled vocabulary, for Biomedicine and related Life Sciences, providing a consistent description for Embase indexing.

    - It offers indexers a comprehensive vocabulary to describe the content of biomedical data;
    - For database users, it facilitates comprehensive searching and high precision retrieval.

    Emtree has been used to index Embase (including Embase Classic) since 1947, and is unrivalled in its coverage of drug and medical terminology.

    In this webinar, Embase Customer Care Representative Dr. Josephine Zimmermann will walk you through:

    - How Emtree is built-up and managed
    - How we index a typical article
    - How drugs, diseases and devices are indexed in Embase

    About the speaker:
    Josephine Zimmermann holds a PhD in Molecular and Structural Chemistry and Physics from University of Grenoble for her research on the synthesis of fluorescent core-shell nanoparticles for medical imaging. Since two years, she works as Customer Care Representative at Elsevier and supports Embase as well as other Life Science Products. She is reporting the voice of the customer by collaborating closely with the Embase team, analyzing tendencies, providing feedback, and helping you with any kind of issues.
  • Reducing efficacy-related failures with PharmaPendium May 22 2018 2:00 pm UTC 60 mins
    Sherry Winter, PhD
    Join us for this 45-minute webinar that will include in-depth information and demonstrations of how to leverage the comparative data in PharmaPendium to reduce the risk of late-stage failures. With a focus on efficacy, we will discuss how PharmaPendium enables you to:

    •find efficacy weaknesses early,
    •identify the most appropriate preclinical models,
    •improve success rates of Phase I and II clinical trial designs by optimising selection of sample size,
    •primary/secondary endpoint and study design and
    •prepare for more effective regulatory reviews
  • Identifying Drug-Drug Interactions using PharmaPendium Recorded: May 2 2018 57 mins
    Sherry Winter, PhD
    * Note the change of date*
    Learn how to identify and assess drug-drug interactions with extracted pharmacokinetic, metabolising enzyme & transporter data and a powerful Drug-Drug Interaction risk calculator
  • Searching for drug safety and benefit-risk evaluations Recorded: Apr 25 2018 56 mins
    Dr. Jean-Dominique Pierret, Scientific Information Expert
    Scientific literature is one of the largest source of adverse event reports, making it an essential part of pharmacovigilance. Marketing authorization holders are expected to perform systematic literature searches using reference databases and local journals from countries where the medicinal product has a marketing authorization. The retrieved information needs to be collated, analyzed, and communicated at least once a week. However, several challenges are associated with this process. Large amounts of data from various sources, various regulatory requirements, building and maintaining search strategies increase the complexity of literature searches.

    In this webinar, Scientific Information Expert Dr. Jean-Dominique Pierret will give a brief overview of regulatory obligations and usefulness of literature in the drug development process. And then he will introduce how he set up literature search for pharmacovigilance: such as selecting the databases, building the strategy with a focus on early detection of safety issue and benefit/risk assessment. Finally, he will give examples of challenges that may occur during literature search for pharmacovigilance.

    About the speaker:
    Dr. Jean-Dominique Pierret is a Scientific Information Expert and he spent +20 years in the pharmaceutical industry. He is currently working for Galderma R&D. With a strong background in information sciences applied to the biomedical domain, he is involved in the management of a corporate scientific library, in competitive intelligence and in information retrieval. Jean-Dominique is in charge for years of the literature survey for pharmacovigilance.
  • Embase for Medical Affairs Recorded: Apr 19 2018 47 mins
    Embase Product Manager: Dr. Iveta Petrova
    Medical affairs teams need quick direct access to the latest literature so they can rapidly respond to client inquiries from anywhere. Embase has unique and comprehensive journal and conference coverage, in-depth indexing that makes it easy to find answers and customizable e-mail alerts that send out regular updates to automate the retrieval of information. Embase specialized capabilities ensure not only comprehensive retrieval of relevant information, but also that it is done in an easy and fast way saving time and money.

    In this session, Elsevier's product manager Dr. Iveta Petrova will demonstrate how Embase can support daily tasks, including:

    - How to design a comprehensive EBM search in just a few steps
    - How to follow innovations in your subject field and related KOLs
    - How to make an indirect comparison between two drugs
    - How to identify opportunities for an investigator initiated trial

    About the speaker:
    Iveta Petrova holds a Ph.D. from Leiden University for research done on Wnt signaling in the nervous system. For the last three years, she is part of the Embase team. Main focus is addressing specific use cases of Medical Affairs professionals by leveraging the capabilities and peer-reviewed enhanced content of the biomedical database Embase, as well as continuous engagement with customers and market research to further improve and develop tools to support them in their daily responsibilities.
  • Leverage PK data in PharmaPendium to inform drug development strategies Recorded: Mar 27 2018 48 mins
    Sherry Winter, PhD
    Pharmacokinetic information from FDA and EMA regulatory documents informs translational and clinical development decisions and may lead to more successful drug development and regulatory approval strategies.

    In this webinar, we will discuss how to leverage comparative pharmacokinetic information from FDA and EMA Drug Approval documents to make better-informed decisions on which drugs have the most potential to succeed in clinical development.
  • Finding the right information for Medical Device Clinical Evaluation and PMS Recorded: Mar 21 2018 62 mins
    Embase Senior Product Manager: Dr. Ivan Krstic
    Information found in the biomedical literature is a significant source for every stage of the medical device life cycle, from concept and design through clinical trials to release and reimbursement, as well as post-market surveillance.

    In June 2016, the updated Medical Device Clinical Evaluation Report (CER) guidelines came into effect (Revision 4 of MEDDEV 2.7/1), detailing where and how to search for literature and how to record the process of collecting, appraising and analyzing the items found.

    In this session, Elsevier's senior product manager Dr. Ivan Krstic demonstrated how Embase is especially suited to help Medical Device manufacturers prepare CER, including:

    - How to design effective literature searches for Clinical Evaluation reports using the PICO search form in Embase;
    - How to build a more comprehensive search using Emtree terms and synonyms;
    - How trade name and manufacturer name indexing supports analyses of devices already on the market;
    - How to find mentions of adverse device reactions in the literature for effective post-market surveillance (PMS) reporting
  • Get more from Reaxys: for Newbies & Reaxys Pros (5pm CET) Recorded: Mar 8 2018 65 mins
    Jurgen Swienty-Busch
    1. Why New Reaxys in the first place
    - What did you miss in old Reaxys without knowing?
    - How to search in new Reaxys and why it is more efficient?
     Reaction searching
     Document searching
     Substance searching

    2. Whats new new?
    - Update on last release and short term roadmap outlook

    3. Where to find additional support (e.g. support center etc)
  • Get more from Reaxys: for Newbies & Reaxys Pros (9am CET) Recorded: Mar 8 2018 64 mins
    Jurgen Swienty-Busch
    1. Why New Reaxys in the first place
    - What did you miss in old Reaxys without knowing?
    - How to search in new Reaxys and why it is more efficient?
     Reaction searching
     Document searching
     Substance searching

    2. Whats new new?
    - Update on last release and short term roadmap outlook

    3. Where to find additional support (e.g. support center etc)
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    Xuanyan Xu
    *Rescheduled: due to the technical issues on Monday, Feb 26. The following webinar has been rescheduled to Monday, Mar 5. We appologoze for any inconvenience and welcome you to join us for the live broadcasting.*

    This is an introductionary webinar on searching the medical literature to answer clinical questions, with a focus on PICO Search Strategies.

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    About Embase
    Embase is a highly versatile, multipurpose and up-to-date biomedical database. It covers the most important international biomedical literature from 1947 to the present day and all articles are indexed in depth using Elsevier's Life Science thesaurus Embase Indexing and Emtree®. The entire database is also conveniently available on multiple platforms.

    Ready to take the next step? Get started with this introductory webinar.
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    Sherry Winter
    Drug safety considerations impact the entire drug development lifecycle, from preclinical safety assessments to clinical trials to post-market.

    In this webinar, we will discuss how to leverage the comparative FDA and EMA regulatory information in PharmaPendium to inform translational and clinical development decisions, as well as to strengthen regulatory approval strategies.
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  • Title: Leverage PK data in PharmaPendium to inform drug development strategies
  • Live at: Mar 27 2018 2:00 pm
  • Presented by: Sherry Winter, PhD
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