de-risking

mindsON Central Monitoring | Episode 4 – Optimizing Clinical Trials: Synergizing Onsite & Centralize (Webinar | Online)

Firma Cyntegrity Germany Webinar , , , , , , , , , ,
mindsON Central Monitoring | Episode 4 – Optimizing Clinical Trials: Synergizing Onsite & Centralize (Webinar | Online)

Language: English

Time: 16.00 to 17.30 h (German time zone, CEST)

Price: 0 € (free of charge)

Webinar:
In response to the growing interest in combining onsite and centralized monitoring approaches, we are excited to have Dr. Yuriy Lebed, CEO of Pharmaxi LLC, a Ukraine-based CRO, along with our CEO, Artem Andrianov, Ph.D., to discuss the latest thinking, examine the challenges organizations encounter in integrating these monitoring methods, and provide practical solutions to overcome these obstacles. In this 90-minute interactive workshop, you’ll have the opportunity to engage with key topics surrounding onsite and centralized monitoring, such as:

• Latest trends and insights on combining onsite and centralized monitoring in clinical trials

• Understanding the challenges in implementing both monitoring approaches

• Practical strategies to address onsite and centralized monitoring-related difficulties

What is a „mindsON Centralized Monitoring workshop“?

mindsON CM is an in-depth workshop series that focuses on the practical aspects of clinical trial monitoring and daily execution. Each episode offers valuable insights, engaging discussions, and hands-on problem-solving exercises to help you overcome the challenges and complexities of monitoring in clinical trials.

Who are the speakers?

  • Artem Andrianov, PhD, MBA, CEO at Cyntegrity: Artem Andrianov has over 20 years of experience in data quality projects (GlaxoSmithKline, Johnson & Johnson, and ERT), RBQM, and data management for the Life Sciences and Medical Devices industries. Artem is a much sought-after, charismatic speaker on RBQM, Spirometry, ECG, Oncology, ePROs, and Clinical Data Management at conferences such as DIA, PCT, DGGF, and PharmaDay. Artem holds a Ph.D. in mathematical modeling and master’s degrees in Business Administration, Financial Management, and Corporate Strategy.

  • Dr. Yuriy Lebed, CEO at Pharmaxi, Deputy director at OnlineCRF, Partner at MD Alliance: After graduating as a general practitioner, Yuriy entered a Ph.D. fellowship program at the Bohomolets Institute National Academy of Sciences. Then he became a co-founder of Pharmaxi CRO in 2013 and is currently CEO at Pharmaxi LLC and Pharmaxi Poland. Pharmaxi, a CRO focused on Ukraine and Poland, provides a complete set of services for clinical trials focusing on regulatory activities, clinical monitoring, and data management. The CRO has a rich experience in the clinical investigation of medicines and medical devices. „OnlineCRF“ is a truly flexible EDC system developed under Yuriy’s supervision and is an excellent tool for clinical data collection and trial monitoring. Yuriy aims to maintain and improve the foundation for organic company growth, establishing an inspiring atmosphere to attract self-motivated and qualified people.

Other RBQM learning resources:

RBQM White Belt, Green Belt & Black Belt Training (eCourse & virtual, instructor-led). Visit the MyRBQM Academy to learn more about our courses, or contact us at tamara.beck@cyntegrity.com.

Eventdatum: Donnerstag, 13. April 2023 16:00 – 17:30

Eventort: Online

Firmenkontakt und Herausgeber der Eventbeschreibung:

Cyntegrity Germany GmbH
Altenhöferallee 3
60438 Frankfurt am Main
Telefon: +49 (0) 6192-470-113-50
https://cyntegrity.com/

Weiterführende Links
Für das oben stehende Event ist allein der jeweils angegebene Herausgeber (siehe Firmenkontakt oben)
verantwortlich. Dieser ist in der Regel auch Urheber der Eventbeschreibung, sowie der angehängten
Bild-, Ton-, Video-, Medien- und Informationsmaterialien. Die United News Network GmbH
übernimmt keine Haftung für die Korrektheit oder Vollständigkeit des dargestellten Events. Auch bei
Übertragungsfehlern oder anderen Störungen haftet sie nur im Fall von Vorsatz oder grober Fahrlässigkeit.
Die Nutzung von hier archivierten Informationen zur Eigeninformation und redaktionellen Weiterverarbeitung
ist in der Regel kostenfrei. Bitte klären Sie vor einer Weiterverwendung urheberrechtliche Fragen mit dem
angegebenen Herausgeber. Eine systematische Speicherung dieser Daten sowie die Verwendung auch von Teilen
dieses Datenbankwerks sind nur mit schriftlicher Genehmigung durch die United News Network GmbH gestattet

mindsON RBQM | Episode 17: RBQM should be standardized, shouldn’t it? (Webinar | Online)

Firma Cyntegrity Germany Webinar , , , , , , , , ,

Language: English

Time: 17.00 to 18.30 h (German time zone, CET)

Price: 0 € (free of charge)

Webinar:

How much of RBQM can be standardized, and how much flexibility is still necessary? Some companies seem to always start from scratch, while others try to standardize as much as possible. What is right and what is wrong with the two approaches? And how can you get the balance right?

What is a „mindsON RBQM workshop“?

mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution, performed by Cyntegrity Germany GmbH – the holistic RBQM solution provider. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share your experiences and participate in the interactive dialog. If you prefer to listen and observe, that’s okay as well.

Who are the speakers?

  • Dr. Johann Proeve (Chief Scientific Officer at Cyntegrity): Johann has over 35 years of experience as a biopharmaceutical industry expert, mainly in the former international role of Head of Global Data Management at Bayer AG. Besides being a much sought-after industry speaker, he brings data-driven realism to the table, ensuring that goals are implementable in the real world. Johann has a vast depth of experience in clinical research, which has been invaluable to many.
  • Keith Dorricott, MBB (Director at DMPI Ltd): Keith has been a qualified Lean Six Sigma Master Black Belt since 2007. He has a solid background in the practical use of process improvement, business process re-engineering, and metrics in clinical trials. Having a wealth of experience across processes in clinical trials and being a frequent speaker at conferences such as SCOPE and the MCC Summit, Keith helps make the complex understandable. In his spare time, he also facilitates and provides thought leadership for workgroups at the MCC, such as Centralized Monitoring, eCOA, and Vendor Oversight.

Other RBQM learning resources:

RBQM White Belt, Green Belt & Black Belt Training (eCourse & virtual, instructor-led). Visit the MyRBQM Academy to learn more about our courses, or contact us at tamara.beck@cyntegrity.com.

Eventdatum: Mittwoch, 28. Juni 2023 17:00 – 18:30

Eventort: Online

Firmenkontakt und Herausgeber der Eventbeschreibung:

Cyntegrity Germany GmbH
Altenhöferallee 3
60438 Frankfurt am Main
Telefon: +49 (0) 6192-470-113-50
https://cyntegrity.com/

Weiterführende Links
Für das oben stehende Event ist allein der jeweils angegebene Herausgeber (siehe Firmenkontakt oben)
verantwortlich. Dieser ist in der Regel auch Urheber der Eventbeschreibung, sowie der angehängten
Bild-, Ton-, Video-, Medien- und Informationsmaterialien. Die United News Network GmbH
übernimmt keine Haftung für die Korrektheit oder Vollständigkeit des dargestellten Events. Auch bei
Übertragungsfehlern oder anderen Störungen haftet sie nur im Fall von Vorsatz oder grober Fahrlässigkeit.
Die Nutzung von hier archivierten Informationen zur Eigeninformation und redaktionellen Weiterverarbeitung
ist in der Regel kostenfrei. Bitte klären Sie vor einer Weiterverwendung urheberrechtliche Fragen mit dem
angegebenen Herausgeber. Eine systematische Speicherung dieser Daten sowie die Verwendung auch von Teilen
dieses Datenbankwerks sind nur mit schriftlicher Genehmigung durch die United News Network GmbH gestattet

mindsON RBQM | Episode 16: RBQM implementation – Which existing roles need change, and what new ones (Webinar | Online)

Firma Cyntegrity Germany Webinar , , , , , , , , ,

Language: English

Time: 17.00 to 18.30 h (German time zone, CET)

Price: 0 € (free of charge)

Webinar:

Since Risk-Based Monitoring was introduced in 2013 by FDA and EMA, organizations have taken many different approaches to implementation. What activities typically need to be performed for RBQM to work well? Which roles usually perform these activities? What new roles are typical, and what has happened to existing roles?

What is a „mindsON RBQM workshop“?

mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution, performed by Cyntegrity Germany GmbH – the holistic RBQM solution provider. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share your experiences and participate in the interactive dialog. If you prefer to listen and observe, that’s okay as well.

Who are the speakers?

  • Dr. Johann Proeve (Chief Scientific Officer at Cyntegrity): Johann has over 35 years of experience as a biopharmaceutical industry expert, mainly in the former international role of Head of Global Data Management at Bayer AG. Besides being a much sought-after industry speaker, he brings data-driven realism to the table, ensuring that goals are implementable in the real world. Johann has a vast depth of experience in clinical research, which has been invaluable to many.
  • Keith Dorricott, MBB (Director at DMPI Ltd): Keith has been a qualified Lean Six Sigma Master Black Belt since 2007. He has a solid background in the practical use of process improvement, business process re-engineering, and metrics in clinical trials. Having a wealth of experience across processes in clinical trials and being a frequent speaker at conferences such as SCOPE and the MCC Summit, Keith helps make the complex understandable. In his spare time, he also facilitates and provides thought leadership for workgroups at the MCC, such as Centralized Monitoring, eCOA, and Vendor Oversight.

Other RBQM learning resources:

RBQM White Belt, Green Belt & Black Belt Training (eCourse & virtual, instructor-led). Visit the MyRBQM Academy to learn more about our courses, or contact us at tamara.beck@cyntegrity.com.

Eventdatum: Mittwoch, 31. Mai 2023 17:00 – 18:30

Eventort: Online

Firmenkontakt und Herausgeber der Eventbeschreibung:

Cyntegrity Germany GmbH
Altenhöferallee 3
60438 Frankfurt am Main
Telefon: +49 (0) 6192-470-113-50
https://cyntegrity.com/

Weiterführende Links
Für das oben stehende Event ist allein der jeweils angegebene Herausgeber (siehe Firmenkontakt oben)
verantwortlich. Dieser ist in der Regel auch Urheber der Eventbeschreibung, sowie der angehängten
Bild-, Ton-, Video-, Medien- und Informationsmaterialien. Die United News Network GmbH
übernimmt keine Haftung für die Korrektheit oder Vollständigkeit des dargestellten Events. Auch bei
Übertragungsfehlern oder anderen Störungen haftet sie nur im Fall von Vorsatz oder grober Fahrlässigkeit.
Die Nutzung von hier archivierten Informationen zur Eigeninformation und redaktionellen Weiterverarbeitung
ist in der Regel kostenfrei. Bitte klären Sie vor einer Weiterverwendung urheberrechtliche Fragen mit dem
angegebenen Herausgeber. Eine systematische Speicherung dieser Daten sowie die Verwendung auch von Teilen
dieses Datenbankwerks sind nur mit schriftlicher Genehmigung durch die United News Network GmbH gestattet

mindsON RBQM | Episode 15: The Risk Assessment is easy, right? Wrong! (Webinar | Online)

Firma Cyntegrity Germany Webinar , , , , , , , , ,
mindsON RBQM | Episode 15: The Risk Assessment is easy, right? Wrong! (Webinar | Online)

Language: English

Time: 17.00 to 18.30 h (German time zone, CET)

Price: 0 € (free of charge)

Webinar:

Describe and discuss the practical challenges with risk assessment. How many risks should you have? Should risks that are for multiple studies be included? Should you only include risks that are study specific? Should the impact score be based on the impact of the whole study or individual patients?

What is a „mindsON RBQM workshop“?

mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution, performed by Cyntegrity Germany GmbH – the holistic RBQM solution provider. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share your experiences and participate in the interactive dialog. If you prefer to listen and observe, that’s okay as well.

Who are the speakers?

  • Dr. Johann Proeve (Chief Scientific Officer at Cyntegrity): Johann has over 35 years of experience as a biopharmaceutical industry expert, mainly in the former international role of Head of Global Data Management at Bayer AG. Besides being a much sought-after industry speaker, he brings data-driven realism to the table, ensuring that goals are implementable in the real world. Johann has a vast depth of experience in clinical research, which has been invaluable to many.
  • Keith Dorricott, MBB (Director at DMPI Ltd): Keith has been a qualified Lean Six Sigma Master Black Belt since 2007. He has a solid background in the practical use of process improvement, business process re-engineering, and metrics in clinical trials. Having a wealth of experience across processes in clinical trials and being a frequent speaker at conferences such as SCOPE and the MCC Summit, Keith helps make the complex understandable. In his spare time, he also facilitates and provides thought leadership for workgroups at the MCC, such as Centralized Monitoring, eCOA, and Vendor Oversight.

Other RBQM learning resources:

RBQM White Belt, Green Belt & Black Belt Training (eCourse & virtual, instructor-led). Visit the MyRBQM Academy to learn more about our courses, or contact us at tamara.beck@cyntegrity.com.

Eventdatum: Mittwoch, 26. April 2023 17:00 – 18:30

Eventort: Online

Firmenkontakt und Herausgeber der Eventbeschreibung:

Cyntegrity Germany GmbH
Altenhöferallee 3
60438 Frankfurt am Main
Telefon: +49 (0) 6192-470-113-50
https://cyntegrity.com/

Weiterführende Links
Für das oben stehende Event ist allein der jeweils angegebene Herausgeber (siehe Firmenkontakt oben)
verantwortlich. Dieser ist in der Regel auch Urheber der Eventbeschreibung, sowie der angehängten
Bild-, Ton-, Video-, Medien- und Informationsmaterialien. Die United News Network GmbH
übernimmt keine Haftung für die Korrektheit oder Vollständigkeit des dargestellten Events. Auch bei
Übertragungsfehlern oder anderen Störungen haftet sie nur im Fall von Vorsatz oder grober Fahrlässigkeit.
Die Nutzung von hier archivierten Informationen zur Eigeninformation und redaktionellen Weiterverarbeitung
ist in der Regel kostenfrei. Bitte klären Sie vor einer Weiterverwendung urheberrechtliche Fragen mit dem
angegebenen Herausgeber. Eine systematische Speicherung dieser Daten sowie die Verwendung auch von Teilen
dieses Datenbankwerks sind nur mit schriftlicher Genehmigung durch die United News Network GmbH gestattet

mindsON RBQM | Episode 14: QTLs – The Return! (Webinar | Online)

Firma Cyntegrity Germany Webinar , , , , , , , , ,

Language: English

Time: 17.00 to 18.30 h (German time zone, CET)

Price: 0 € (free of charge)

Webinar:

We ran a workshop on QTLs in 2022 and were inundated with questions. So we thought we needed to return to the subject! We will explore the latest thinking on QTLs, discuss why organizations find them so challenging to implement, suggest practical approaches, and have plenty of opportunity for lots more of your questions.

What is a „mindsON RBQM workshop“?

mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution, performed by Cyntegrity Germany GmbH – the holistic RBQM solution provider. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share your experiences and participate in the interactive dialog. If you prefer to listen and observe, that’s okay as well.

Who are the speakers?

  • Dr. Johann Proeve (Chief Scientific Officer at Cyntegrity): Johann has over 35 years of experience as a biopharmaceutical industry expert, mainly in the former international role of Head of Global Data Management at Bayer AG. Besides being a much sought-after industry speaker, he brings data-driven realism to the table, ensuring that goals are implementable in the real world. Johann has a vast depth of experience in clinical research, which has been invaluable to many.
  • Keith Dorricott, MBB (Director at DMPI Ltd): Keith has been a qualified Lean Six Sigma Master Black Belt since 2007. He has a solid background in the practical use of process improvement, business process re-engineering, and metrics in clinical trials. Having a wealth of experience across processes in clinical trials and being a frequent speaker at conferences such as SCOPE and the MCC Summit, Keith helps make the complex understandable. In his spare time, he also facilitates and provides thought leadership for workgroups at the MCC, such as Centralized Monitoring, eCOA, and Vendor Oversight.

Other RBQM learning resources:

RBQM White Belt, Green Belt & Black Belt Training (eCourse & virtual, instructor-led). Visit the MyRBQM Academy to learn more about our courses, or contact us at tamara.beck@cyntegrity.com.

Eventdatum: Mittwoch, 22. März 2023 17:00 – 18:30

Eventort: Online

Firmenkontakt und Herausgeber der Eventbeschreibung:

Cyntegrity Germany GmbH
Altenhöferallee 3
60438 Frankfurt am Main
Telefon: +49 (0) 6192-470-113-50
https://cyntegrity.com/

Weiterführende Links
Für das oben stehende Event ist allein der jeweils angegebene Herausgeber (siehe Firmenkontakt oben)
verantwortlich. Dieser ist in der Regel auch Urheber der Eventbeschreibung, sowie der angehängten
Bild-, Ton-, Video-, Medien- und Informationsmaterialien. Die United News Network GmbH
übernimmt keine Haftung für die Korrektheit oder Vollständigkeit des dargestellten Events. Auch bei
Übertragungsfehlern oder anderen Störungen haftet sie nur im Fall von Vorsatz oder grober Fahrlässigkeit.
Die Nutzung von hier archivierten Informationen zur Eigeninformation und redaktionellen Weiterverarbeitung
ist in der Regel kostenfrei. Bitte klären Sie vor einer Weiterverwendung urheberrechtliche Fragen mit dem
angegebenen Herausgeber. Eine systematische Speicherung dieser Daten sowie die Verwendung auch von Teilen
dieses Datenbankwerks sind nur mit schriftlicher Genehmigung durch die United News Network GmbH gestattet