Paediatric Drug Development & Clinical Trials
Paediatric Drug Development & Clinical Trials

Course Description

This 2-day online course provides an overview of medical, regulatory, ethical, organisational and practical aspects of designing and performing clinical trials with paediatric patients. It is designed to help you navigate the regulatory landscape and maintain sound practices in patient recruitment and protocol writing. 
  • EMA & FDA Regulatory Requirements for Pediatric Clinical Trials 
  • PIP& iPSP 
  • PREA v. BPCA Requirements for Pediatric Clinical Trials 
  • Waivers & Deferrals 
  • Paediatric trial methodologies 
  • Protocol Writing during Paediatric Research 
  • Patient Recruitment & Ethical Challenges 
  • Company Strategies 
  • EMA & FDA expectations for paediatric clinical trials - ethical and regulatory considerations 
  • Practical implementation of regulatory expectations 
  • How to design a paediatric study - study endpoints and outcome measures 
  • How to utilise social media, advocacy groups and work effectively with children’s hospitals 
  • Overcome the challenges of paediatric patient recruitment 
  • How to interact with regulatory bodies 
  • Understand requirements to address unmet therapeutic/diagnostic needs 

Paediatric Drug Development & Clinical Trials (US)

13 - 14 June 2024, Live Online Training
€1.650,00
Dr. Karl-Heinz Huemer

Dr. Huemer received his MD in medicine at the Medical University of Vienna and his PhD in Biology at the University of Vienna and subsequently specialized in Medical Physiology, followed by a long medical career in research, teaching and medical practice. Between 2007 - 2023 he worked at the Austrian Medicines & Medical Devices Agency.

START TIMES

5:00 PM Vienna time

4:00 PM London time

11:00 AM New York time

8:00 AM Los Angeles time

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Course Description

This 2-day online course provides an overview of medical, regulatory, ethical, organisational and practical aspects of designing and performing clinical trials with paediatric patients. It is designed to help you navigate the regulatory landscape and maintain sound practices in patient recruitment and protocol writing. 
  • EMA & FDA Regulatory Requirements for Pediatric Clinical Trials 
  • PIP& iPSP 
  • PREA v. BPCA Requirements for Pediatric Clinical Trials 
  • Waivers & Deferrals 
  • Paediatric trial methodologies 
  • Protocol Writing during Paediatric Research 
  • Patient Recruitment & Ethical Challenges 
  • Company Strategies 
  • EMA & FDA expectations for paediatric clinical trials - ethical and regulatory considerations 
  • Practical implementation of regulatory expectations 
  • How to design a paediatric study - study endpoints and outcome measures 
  • How to utilise social media, advocacy groups and work effectively with children’s hospitals 
  • Overcome the challenges of paediatric patient recruitment 
  • How to interact with regulatory bodies 
  • Understand requirements to address unmet therapeutic/diagnostic needs 

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Paediatric Drug Development & Clinical Trials (US)

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

Medical-Devices-Certificate-Course

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