2025-05-28 2025-05-28 , online online, 1,290 € zzgl. MwSt. Dr. Uta Buckpesch-Heberer https://forum-institut.de/seminar/25112552-early-phase-complex-clinial-trials/referenten/25/25_11/25112552-course-early-phase-complex-clinial-trials_buckpesch-heberer-uta.jpg Early Phase Complex Clinial Trials

Do you want to strategically plan your early phase clinical trials (phase I/IIa) from the start to accelerate drug development? Then gain tips and hands-on experience in this online seminar!

Topics
  • The regulatory framework of phase I/IIa trials
  • A combination of early study phases - when conceivable?
  • Internal strategic considerations for study design: resources, costs, logistics
  • Operational implementation: design development and "integrated" early phase protocol
  • The PEI perspective on early phase complex trials: risk management, safety monitoring, study amendments


Who should attend
This seminar will be of benefit to all those working in the pharmaceutical industry who are responsible for the planning and conducting of early phase clinical trials (phase I/IIa) and who want to learn about:
  • the possibilities offered by combined study designs
  • key considerations in the strategic planning of complex study processes
  • regulatory perspectives on the evaluation of such complex study designs.

This course will be conducted in English.
Aims and objectives
A strategically well-planned drug development process offers a significant market advantage for pharmaceutical companies.

In this seminar, you will learn how to strategically align your early-phase studies (phase I/IIa) to maximise insights with minimal time investment.
  • What should you consider regarding the translation of preclinical experiences and dose selection?
  • How do regulatory authorities evaluate potential ideas and plans for combined study phases?
  • And how can the guidelines be practically implemented in terms of study protocol design, risk management, and safety monitoring?

Gain the necessary know-how and valuable hands-on experience in this seminar to efficiently align your drug development in early clinical trial phases.
Your benefit

With the knowledge imparted in the seminar, you will:

  • understand the possibilities and limitations of combined study designs.
  • be able to assess how regulatory authorities will evaluate your plans.
  • know how to strategically approach the planning of your drug development phases.

Course Early Phase Complex Clinial Trials

Early Phase Complex Clinial Trials

Strategic Considerations for Study Design in Phase I/IIa Trials

Benefits
  • Strategic considerations: how to improve your study design for phase I/IIa?
  • The perspective of regulatory authorities
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25112552

Jetzt buchen

JETZT Buchen
Referenten

Dr. Uta Buckpesch-Heberer

Paul-Ehrlich-Institut Federal Institute for Vaccines and Biomedicines, Langen

Dr. Mazyar Mahmoudi

Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß

Clinical Program Lead

Alles auf einen Blick

Termin

14/11/2025

14/11/2025

Zeitraum

09:00-17:00
You may dial in 30 minutes before the session starts.

09:00-17:00
You may dial in 30 minutes before the session starts.
Veranstaltungsort

online

online

Downloads
Overview of Changes ICH E6(R2) to (R3)
Overview of Changes ICH E6(R2) to (R3)
Gebühr

Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Regine Görner
Dr. Verena Klüver

r.goerner@forum-institut.de
v.kluever@forum-institut.de

Details

Do you want to strategically plan your early phase clinical trials (phase I/IIa) from the start to accelerate drug development? Then gain tips and hands-on experience in this online seminar!

Topics

  • The regulatory framework of phase I/IIa trials
  • A combination of early study phases - when conceivable?
  • Internal strategic considerations for study design: resources, costs, logistics
  • Operational implementation: design development and "integrated" early phase protocol
  • The PEI perspective on early phase complex trials: risk management, safety monitoring, study amendments


Who should attend
This seminar will be of benefit to all those working in the pharmaceutical industry who are responsible for the planning and conducting of early phase clinical trials (phase I/IIa) and who want to learn about:
  • the possibilities offered by combined study designs
  • key considerations in the strategic planning of complex study processes
  • regulatory perspectives on the evaluation of such complex study designs.

This course will be conducted in English.

Aims and objectives

A strategically well-planned drug development process offers a significant market advantage for pharmaceutical companies.

In this seminar, you will learn how to strategically align your early-phase studies (phase I/IIa) to maximise insights with minimal time investment.

  • What should you consider regarding the translation of preclinical experiences and dose selection?
  • How do regulatory authorities evaluate potential ideas and plans for combined study phases?
  • And how can the guidelines be practically implemented in terms of study protocol design, risk management, and safety monitoring?

Gain the necessary know-how and valuable hands-on experience in this seminar to efficiently align your drug development in early clinical trial phases.

Your benefit

With the knowledge imparted in the seminar, you will:

  • understand the possibilities and limitations of combined study designs.
  • be able to assess how regulatory authorities will evaluate your plans.
  • know how to strategically approach the planning of your drug development phases.

Detailed programme

09:00-17:00
You may dial in 30 minutes before the session starts.

Welcome and introduction


Dr Mazyar Mahmoudi

Regulatory framework and general scope of phase I/IIa trials
  • EMEA/CHMP/SWP/28367/07 Rev. 1
  • ICH E6 (R3)
  • EU Clinical Trials Regulation 536/2014
  • FDA guidelines
  • Considerations for (pre-)clinical development programs
  • Pharmacodynamics, pharmacokinetics, safety studies
  • Translation and dose selection
  • Risk assessments - "Go/No-go" decision criteria

Dr Mazyar Mahmoudi

Strategic considerations for study design - traditional or combined?
  • Combination possibilities of sequential substudiesWith single/multiple ascending doses (SAD/MAD)
    • Interaction studies with food/other drugs, including PD study
  • When is a combination of early study phases even conceivable?
  • A question of costs
  • Internal company resources - what needs to be considered? Stakeholder buy-in
  • Communication plans for early detection/forwarding of safety signals
  • Logistics of clinical trials (trial sites, training, safety monitoring, etc.)

Dr Mazyar Mahmoudi

Operational implementation: design development and "integrated" early phase protocol
  • Criteria for a transition from healthy individuals to patients
  • Patient population and sample size, site selection
  • Dose levels (schedules for dose escalation and reduction)
  • Changes in the benefit-risk ratio (laboratory values, AEs etc.)
  • Evaluation of substudies
  • Safety monitoringAppointment of Data Safety Monitoring Boards (DSMB)/Safety Review Committees
    • Acceptance of laboratory value changes
    • AE frequency limits and grouping by organ class
  • Termination criteria/criteria for dose limiting toxicities
  • Protocol amendments, communication with authorities
  • Follow-up of substudies

Dr Uta Buckpesch-Heberer

Regulatory considerations: PEI perspective on early phase complex trials
  • "Leitplankenkonzept"
  • Rationale for study designs, selection of endpoints or statistical planning
  • Expectations regarding the qualifications of investigators and study sites
  • Requirements for risk management and safety monitoring
  • Criteria for the approval of study amendments

Closing discussion

Further information

Technical requirements

You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.

We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.

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