2025-01-22 2025-01-22 , online online, 1,290 € zzgl. MwSt. Dr. Gesine Bejeuhr https://forum-institut.de/seminar/25052552-paediatric-drug-development-strategies-for-success/referenten/25/25_05/25052552-course-paediatric-drug-development_bejeuhr-gesine.jpg Paediatric Drug Development: Strategies for Success

Would you like to plan your paediatric clinical trials strategically and conduct them efficiently in practice? Then attend this online seminar and benefit from comprehensive knowledge transfer and the practical experience of paediatric experts!

Topics
  • Global regulatory landscape for paediatric clinical trials
  • Assessment of paediatric investigation plans in the EU: what do the authorities expect?
  • Strategic considerations for paediatric clinical trial design: content-related and organisational aspects
  • Conducting paediatric clinical trials: hands-on experience


Who should attend
This seminar will be of benefit to all those working in clinical, medical or regulatory affairs, who are responsible for the planning and conducting of paediatric clinical trials and who want to learn about:

  • the regulatory and ethical requirements in paediatric clinical trials
  • the key considerations in their strategic planning
  • practical tips for conducting those specific trials.

This course will be conducted in English.
Aims and objectives
Paediatric clinical trials are an essential part of drug development. Those who position themselves strategically and plan and conduct the trials carefully will benefit on the drug development timeline.

In this seminar, you will learn about the regulatory requirements for paediatric clinical trials and how paediatric investigation plans as well as study concepts are assessed in the EU.
What are the key design considerations for paediatric clinical trials in terms of preclinical data, toxicology and formulation? How can existing data be optimally used in practice? And what opportunities are there to involve paediatric patients and their parents in clinical studies - keyword patient-centred study design?

Attend this seminar to get informed.
Your benefit

With the knowledge imparted in the seminar, you will

  • understand the regulatory framework for paediatric clinical trials.
  • be able to adhere to the requirements of the authorities.
  • know how to plan your studies and conduct them efficiently in practice.

Course Paediatric Drug Development

Paediatric Drug Development: Strategies for Success

Regulatory Framework, Planning and Conducting Paediatric Clinical Trials

Benefits
  • Strategic considerations: how to improve your drug development timeline?
  • Assessment of paediatric investigation plans in the EU
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25052552

Jetzt buchen

JETZT Buchen
Referenten

Dr. Gesine Bejeuhr

Bayer AG, Berlin

Pediatric Regulatory Leader

Dr. Stefanie Breitenstein

Formaly Global Clinical Leader Pediatric Development at Bayer AG

Dr. Sabine Scherer

-requested- Senior Expert Regulatory Affairs und Paediatrics, Bonn

Senior Expert Regulatory Affairs und Paediatrics, Bonn Paediatrician and adolescent medicine specialist

Dr. Frank Tennigkeit

UCB Biosciences GmbH, Monheim

Senior Clinical Program Director Pediatric Development

Alles auf einen Blick

Termin

14/05/2025

14/05/2025

Zeitraum

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

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

online

online

Downloads
Abbreviation List Clinical Research
Abbreviation List Clinical Research
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

Would you like to plan your paediatric clinical trials strategically and conduct them efficiently in practice? Then attend this online seminar and benefit from comprehensive knowledge transfer and the practical experience of paediatric experts!

Topics

  • Global regulatory landscape for paediatric clinical trials
  • Assessment of paediatric investigation plans in the EU: what do the authorities expect?
  • Strategic considerations for paediatric clinical trial design: content-related and organisational aspects
  • Conducting paediatric clinical trials: hands-on experience


Who should attend
This seminar will be of benefit to all those working in clinical, medical or regulatory affairs, who are responsible for the planning and conducting of paediatric clinical trials and who want to learn about:

  • the regulatory and ethical requirements in paediatric clinical trials
  • the key considerations in their strategic planning
  • practical tips for conducting those specific trials.

This course will be conducted in English.

Aims and objectives

Paediatric clinical trials are an essential part of drug development. Those who position themselves strategically and plan and conduct the trials carefully will benefit on the drug development timeline.

In this seminar, you will learn about the regulatory requirements for paediatric clinical trials and how paediatric investigation plans as well as study concepts are assessed in the EU.
What are the key design considerations for paediatric clinical trials in terms of preclinical data, toxicology and formulation? How can existing data be optimally used in practice? And what opportunities are there to involve paediatric patients and their parents in clinical studies - keyword patient-centred study design?

Attend this seminar to get informed.

Your benefit

With the knowledge imparted in the seminar, you will

  • understand the regulatory framework for paediatric clinical trials.
  • be able to adhere to the requirements of the authorities.
  • know how to plan your studies and conduct them efficiently in practice.

Detailed programme

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

Start of the course: Welcome and introduction

Dr Gesine Bejeuhr

Global regulatory landscape for paediatric clinical trials
  • Key regulations and regulatory authorities worldwide (FDA, EMA, PMDA, etc.)
  • Regional differences in regulatory requirements and timelines
  • Ethical considerations in paediatric clinical trials
  • Outlook on expected changes in the EU pharmaceutical strategy

Dr Sabine Scherer

Assessment of paediatric investigation plans in the EU
  • Waiver/deferral
  • Signifcant benefit
  • Stepwise PIP
  • PDCO PIP assessment, recurring issues

Coffee break


Dr Stefanie Breitenstein, Dr Frank Tennigkeit

Strategic considerations for paediatric clinical trial design
  • "Paediatric-only" indication - rare paediatric disease - "orphan drug" status - expansion of an adult approval: strategic similarities and differences
  • Timeline and organisational aspects: literature search, document structure, stakeholder buy-in, etc.
  • Preclinical data, toxicology, and formulation
  • Considerations for study design: patient numbers, age groups, endpoints, child-friendly study design - paediatric specificities.
  • The whole picture: evidence transfer, drug approval and HTA

Lunch break


Dr Stefanie Breitenstein, Dr Frank Tennigkeit

Continuation strategic considerations

Dr Stefanie Breitenstein, Dr Frank Tennigkeit

Practical tips for conducting paediatric clinical trials
  • Optimal use of available data: modelling, simulation, extrapolation (ICH E11A on paediatric extrapolation)
  • Informed consent
  • Real-world case studies and lessons learned
    • Patient-centred study design - involving patient/parent organisations in the planning and conduct of studies
    • Challenges in patient recruitment and potential solutions: collaborating with networks

Coffee break


Dr Stefanie Breitenstein, Dr Frank Tennigkeit

Continuation practical tips

Q&A Session


End of the seminar


Further information

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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