Clinical Trial Drug Supply Predictions Making Them Realistic and Near Real-Time

Time

16:00 - 17:30

Date

Mar 24 2022
Expired!

Learning Type

Free Live Webinar

Overview


Clinical trial drug supply requirements depend on when Patient Visits occur, and CMOs and CDMOs are criticized for not providing the drug supplies on time and budget. However, they struggle to improve their performance because those who plan and oversee the clinical trials don’t have a satisfactory way to indicate when Patient Visits will occur. 

As a result, the CMOs and CDMOs cannot efficiently sequence their manufacturing campaigns and follow-on steps, resulting in waste levels that can reach 80%. 

In this webinar, Steve Glan will show you that more accurate clinical trial drug supply predictions are possible, even when things go wrong during trial execution. 

Steve has spent the last decade making clinical trial design and execution predictable, efficient, and transparent by applying his knowledge of engineering, manufacturing, clinical operations, math, and software development to large sets of clinical trial data. 

By the end of the webinar, you will see the explicit connection between Patient Visits and clinical trial drug supply, improving planning between CROs/Pharma ClinOps and CMOs/CDMOas.

 

Who should attend?

Anyone who wants to understand a clinical trial from a process perspective, CMOs/CDMOs, CROs, and ClinOps personnel.

  • Skill Level: Novice, Intermediate , Expert
  • Topics:

    1. Understanding What A Clinical Trial Is
    1.1 Air Traffic Control Analogy
    1.2 Process View of a Clinical Trial

    2 Patient Visits: Connecting the Clinical Trial to Clinical Drug Supply
    2.1 Starting at the End: On-Site Drug Supply Needs
    2.2 Backing Up: Drug at Depots, Drug Shipped, Drug Packaged/Released, Drug   Manufactured

    3. The Path Forward: Integrating Clinical Operations and Drug Supply

Speaker

  • Steve Galen
    Steve Galen
    Owner at Galen F P Solutions

    Steve has a Ph.D. in Engineering and more than 27 years of experience in Big Pharma and global CROs. He has run the CRO division of a life sciences company and held senior leadership positions in clinical operations, software development, risk-based monitoring, clinical data science, project management, drug development, and pharmaceutical manufacturing, including clinical trial drug supply. Steve has spent the last decade making clinical trial design and execution predictable, efficient, and transparent by applying his knowledge of engineering, manufacturing, clinical operations, math, and software development to large sets of clinical trial data. Steve asserts that a clinical trial is not an AI/ML “black box” but rather a set of characterizable and connected processes that predictably produces data, like a manufacturing line. Steve is keenly aware that ROI matters when designing and running trials. His approach makes it easy to determine ROI before committing to a course of action intended to improve trial performance.

What people are saying

Àngels Llarch
Àngels LlarchPharmacist
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Honestly, I thought it would be a kind of refreshment training. Thank you for the quality of the content, the motivation, and for making us vibrate as if we were in the same classroom. ‎
Olivera Tatalovic PMP, CSSGB, Economist
Olivera Tatalovic PMP, CSSGB, EconomistQuality Assurance * Regulatory Projects, Operations & Compliance * EU and MENA region * An alumna of Pfizer & Smith+Nephew
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Thank you Alex Hall and Yan Kugel for one more training with really valuable content provided. I have thoroughly enjoyed it. #qms #qualityassurance
Avanish Kansara
Avanish KansaraQA Manager at Althea
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Thanks Yan & Alex for organising this event. It was great learning and knowledge sharing by Alex and QA experts from all over the world on how CAPA plays important role in improving Quality System. Looking forward for upcoming events to learn other aspects of Quality System and improving myself.
Victoria De La Mare
Victoria De La MareQuality Assurance Specialist
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Yet another very informative session with Alex Hall and Yan Kugel. Extremely useful pointers for change control and deviation management. Thank you once again!
Ramya Raghavendra
Ramya RaghavendraQuality Control Specialist (Stability) at Seqirus
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Thank you, Yan Kugel and Alex Hall for the opportunity to be a part of an amazing and informative webinar with Qualistery GmbH.
Dayna Gabell-Jopson BSc RSci
Dayna Gabell-Jopson BSc RSciQuality Assurance Officer at Bray Group
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Fantastic webinar, very informative, lots of novel ideas and it was run at a good pace. Alex is also very entertaining and makes Quality fun! Thank you Alex Hall, Yan Kugel and Qualistery GmbH #quality #webinar
Jenifer Anigbogu
Jenifer AnigboguQuality Assurance, Regulatory affairs, and Export specialist at Metrovision
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Thank you to Yan Kugel, Alex Hall and Qualistery GmbH for organising this webinar on how to continually improve your quality system - a very engaging and informative presentation.
Sona Ledinia
Sona LediniaFresh Graduate Pharmacist | Passionate and enterprising in being more knowledgeable and skilful in the Pharmaceutical Industry.
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I had a chance to joined a great!, great training webinar by Qualistery GmbH about "How To Take Control Over Your Deviations". Thanks to Yan Kugel, Alex Hall and Qualistery GmbH for giving me this opportunity to acquire such valuable information and mindset to have in maintaining the Quality. Deviations surely the important matter to control so we could get the safest and the best quality we want.
Stefano De Blasis
Stefano De BlasisSite Compliance Specialist (Regulatory Affairs) in Pfizer Italia S.r.l.
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First rule in this dynamic world: Never stop learning! 💪 Thanks to Yan Kugel and Qualistery GmbH for the opportunity to partecipate to this webinar.
Annalisa D'orazio
Annalisa D'orazioQuality Assurance Specialist at GSK
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Another great session about best practices on How to take control over deviations! Very grateful to receive insights on how to reduce the number of reoccurring deviations and improve KPI's, avoiding waste of time and reducing risk. Thanks to Alex Hall Yan Kugel Qualistery GmbH I really invite to have a look on upcoming sessions!
아템켕에드몬드
아템켕에드몬드Quality Assurance Manager at Medytox Inc.
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Much appreciation to Yan Kugel and the team at Qualistery GmbH for putting together this training. The training material and manner of presentation was truly unique in its own captivating the audience and naturally increases attention span and concentration through out the session.
Floriana Vetrano
Floriana VetranoChemical engineer
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Thanks Yan Kugel, Alex Hall and Qualistery GmbH for the Great Webinar “ How To Take Control Over Your Deviations” with very useful insight on Issue Management and Recurring Deviations! Well done!
Martina Gjorgjevska
Martina GjorgjevskaQuality Assurance Pharmacist at VARUS
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Thank you all for this great webinar. It was really insightful with great tips to implement in our quality system. Continue with the great work 👏
Nadica Mireva Popovska
Nadica Mireva PopovskaResearch And Development Manager at Galafarm
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Yan Kugel Alex Hall, thank you for the informative webinar. You did a nice job👏
Amritha Mukundan
Amritha MukundanQuality Control Professional
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The training I attended was excellent. The instructor was very knowledgeable and shared great insights that I definitely plan to use. I am looking forward to the next Webinars and Workshops.
Ahmad Al Turman
Ahmad Al TurmanQuality Control Compliance Supervisor at MS PHARMA
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Qualistery has an attractive way to preset their topics. Additionally, the explanations by the trainer were simple and wonderful. I wish you progress and success as I await what comes next.
Miguel Enseñat Mestre
Miguel Enseñat MestreGlobal Production manager and Logistics manager en Labolife España S.A.
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SOPs are the basis for maintaining the consistency and quality of a process, thanks to Qualistery GmbH Yan Kugel and Yogesh Krishan Davé for giving us the opportunity to receive valuable information in a convenient way.
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Local Time

  • Timezone: Europe/Amsterdam
  • Date: Mar 24 2022
  • Time: 16:00 - 17:30

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