2026-02-04 2026-02-04 , online online, 1,290 € zzgl. MwSt. Dr. Uta Buckpesch-Heberer https://forum-institut.de/seminar/26092551-early-phase-complex-clinial-trials/referenten/26/26_09/26092551-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 get tips and hands-on experience regarding traditional and complex clinical studies in this online seminar!

Topics
  • General scope of phase I/IIa trials: development plan, risk assessment, Go/No-Go decision criteria
  • Strategic considerations of early clinical trial designs - traditional vs. complex
  • Operational implementation of complex early phase protocols
  • The PEI perspective on early phase complex trials: "Guard Rail Concept" - study design, stopping rules and the decision making process


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 traditional as well as complex early clinical trial phases.
Your benefit

With the knowledge imparted in the seminar, you will:

  • understand the possibilities and limitations of complex and 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 26092551

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

25/09/2026

25/09/2026

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

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

Event - 1,290€ plus tax
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 get tips and hands-on experience regarding traditional and complex clinical studies in this online seminar!

Topics

  • General scope of phase I/IIa trials: development plan, risk assessment, Go/No-Go decision criteria
  • Strategic considerations of early clinical trial designs - traditional vs. complex
  • Operational implementation of complex early phase protocols
  • The PEI perspective on early phase complex trials: "Guard Rail Concept" - study design, stopping rules and the decision making process


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 traditional as well as complex early clinical trial phases.

Your benefit

With the knowledge imparted in the seminar, you will:

  • understand the possibilities and limitations of complex and 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

General scope of early phase clinical trials
  • Introduction
  • Overview of preclinical and clinical development
  • Development plan
    • Risk assessmentsGo/No-Go decision criteria
    • Target product profile (TPP)
  • Overview of early phase clinical trial objectives
    • Preliminary safety
    • Pharmacokinetic and pharmacodynamic assessment

Dr. Mazyar Mahmoudi

Strategic considerations of early clinical trial designs - traditional vs. complex
  • Introduction/overview of design principles
  • Traditional (rule-based) designs
    • Introduction
    • Statistical foundation: frequentist framework
    • Single ascending dose (rule-based)
    • Multiple ascending dose (rule-based)
    • Bioequivalence and bioavailibility (cross-over)
    • Drug-Interaction
    • Proof-of-Concept (rule-based)

Dr Mazyar Mahmoudi

Strategic considerations of early clinical trial designs - traditional vs. complex (continuing)
  • Complex designs
    • Introduction
    • Statistical foundation: Bayesian framework
    • Single ascending dose (adaptive)
    • Multiple ascending dose (adaptive)
    • Proof-of-Concept (adaptive)
    • Seamless adaptive designs
    • Integrated (Combined) early phase protocols
    • Evaluation of substudies
    • Protocol amendmentsFeasibility of complex early phase clinical trials

Dr Uta Buckpesch-Heberer

Regulatory considerations: PEI perspective on early phase complex trials
  • General aspects of trial approval
  • CTIS and the assessment process
  • The regulatory perspective
  • Lessons learned
  • The "Guard Rail Concept": study design, stopping rules and the decision making process
  • Criteria for Substantial Amendments
  • Case studies to illustrate the regulatory process (with quiz)

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.

This distinguishes our events

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Valuable insights into complex clinical trial planning

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