Autor: Firma Cyntegrity Germany

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

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

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/

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)

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

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/

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)

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/

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)

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

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/

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 Global Risk Management | How Ukraine-based CRO adopts war as opportunity (Webinar | Online)

mindsON Global Risk Management | How Ukraine-based CRO adopts war as opportunity (Webinar | Online)

A War – A Low Probability Risk with High Impact

In this special episode of mindsON Global Risk Management, our CEO, Artem Andrianov, Ph.D., speaks with Dr. Yuriy Lebed, the CEO of Pharmaxi LLC, a CRO based in Kyiv, Ukraine, that works with BioPharma and Medical Device companies across the globe.

As a data science organization that is entirely focused on de-risking clinical trials and their conduct, tackling the unique set of risks that have low probability but have high, often global impact, is an objective that has been on our minds since the COVID-19 outbreak. What if we could predict and mitigate global threats such as pandemics, wars, and energy crises ahead of time?

Once a crisis is in motion, turning it into an opportunity often requires new ways of seeing, thinking, and responding. Yuriy and his team are a living example of this unfortunate event by establishing much-needed survival mechanisms to enable their organization to continue its activities, providing life-changing treatments to patients in Ukraine.

Victims of war – continued access to investigational medicines and treatments

While others withdrew, Yuriy and his team seized the opportunity to reach out to unique patient groups made possible by the war and successfully kept their sites open. In this challenging environment, his CRO helps victims of war by facilitating acute, on-site treatment as part of continued clinical studies.

___

In an interview just after the outbreak of war, Yuriy said he was as shocked as many that Russia would invade its neighbor. The attack forced him to relocate with his family to Lviv, in the western part of the country. From there, he’s been able to lead the CRO as it keeps many clinical trials running. He calls the country’s [health] regulators “heroes” for vowing to process approvals while the capital city is bombed. He also says Pharmaxi is already planning for the future, which includes expanding operations into Poland and working within EU countries. 

About mindsON Global Risk Management

What if we could predict and mitigate global risks such as pandemics, wars, and energy crises ahead of time? What would your organization look like?

Recent catastrophic events such as the Ukraine-Russia war and COVID-19 have spotlighted drug discovery, development, manufacturing, and supply chain and exposed the current system’s deficiencies. At the same time, it has given a glimpse of what can be possible today and how ready the system is for innovation, acceleration, and implementation of needed changes around what, how, and by whom global risk is proactively managed.

In parallel, the digital revolution has increased the availability of data, degree of connectivity, and speed at which decisions are made. Digitization offers transformational promise but also comes with the potential for large-scale failure and security breaches, together with a rapid cascading of consequences.

Lebed and Andrianov discuss an outlook on the expanding horizons for risk management in pharma – solving tomorrow’s problems with today’s data, technology, and expertise.

Join us and be part of the live discussion!

Eventdatum: Montag, 05. Dezember 2022 16:30 – 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/

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

Für die oben stehenden Pressemitteilungen, das angezeigte Event bzw. das Stellenangebot sowie für das angezeigte Bild- und Tonmaterial ist allein der jeweils angegebene Herausgeber verantwortlich. Dieser ist in der Regel auch Urheber der Pressetexte sowie der angehängten Bild-, Ton- und Informationsmaterialien. Die Nutzung von hier veröffentlichten Informationen zur Eigeninformation und redaktionellen Weiterverarbeitung ist in der Regel kostenfrei. Bitte klären Sie vor einer Weiterverwendung urheberrechtliche Fragen mit dem angegebenen Herausgeber.