Pediatric Clinical Development MasterClass - US edition

04-05 December, 2024

Beyond Child's Play

We will navigate the intricacies of the regulatory frameworks, pediatric development planning and trial design and ethical, organizational and practical aspects of pediatric clinical trial conduct.

04-05 December, 2024, Virtual

Time Zone : Eastern Standard Time (EST) - UTC05:00

GET THE AGENDA NOW

Key learnings

Importance

Importance of Pediatric Clinical Development and its impact on global health

Advancements and Gaps

Acknowledging the existing gaps that require attention, fostering a comprehensive view of the field

Regulatory Landscape

Gain insight into pediatric drug development regulations, incentives, requirements, and recent regulatory changes, ensuring compliance with the evolving legal framework

Pediatric Developmental Concepts

Grasp the significance of pediatric developmental concepts, such as organ maturation, and their influence on pharmacokinetics and pharmacodynamics

Pediatric Development Plan

Identify the key elements of a pediatric development plan

Age-Appropriate Medications

Understand the factors determining age-appropriate dosing and drug formulations, ensuring the safety and efficacy of pediatric treatments

Trusted by over 17,000 delegates across leading companies

GET THE AGENDA NOW

Overview

Physicians often find themselves facing a challenging dilemma: how to provide the best possible care for their youngest patients when the toolbox of approved medicines for children remains frustratingly sparse. The issue of off-label drug use in pediatrics looms large, with over 40% of drugs prescribed without evidence based pediatric approvals. In an effort to transform this landscape, significant strides have been taken, such as in the United States through legislative acts like the Best Pharmaceuticals for Children Act (BPCA), the Pediatric Research Equity Act (PREA), and the RACE for Children Act. This course is designed to provide an overview and understanding of the legal, scientific, operational, and participant elements at the heart of pediatric clinical research. Join us to gain insights into the complexities of pediatric clinical trials and the vital role they play. Together, well navigate the intricacies of the regulatory frameworks, pediatric development planning and trial design and ethical, organizational and practical aspects of pediatric clinical trial conduct.

#masterclass #pharmaonlinemasterclass #glceurope #globalleadingconferences #pediatricdrugdevelopment

Trainer

Dr. Jacqui Whiteway, PhD

Senior Director Centre for Pediatric Clinical Development
ICON Plc

Dr. Jacqui Whiteway, PhD brings more than 20 years scientific and leadership experience in the clinical research industry to her current role as Senior Director and Head Pediatric Strategy Liaison in the Centre for Pediatric Clinical Development (CPCD) at ICON, a leading global CRO. Her PhD in Molecular Biology and research and preclinical experience gained through cancer genomics research and in a startup biotech company inspired her to pursue the unique challenges of clinical trials. Her industry and leadership experience grew in the CRO environment through a variety of roles from Biometrics to Therapeutic Expertise, including leading a Global Feasibility team before joining the CPCD. Through her roles, Jacqui has contributed to over 500 clinical studies for over 250 sponsors across all therapeutic areas and phases.

Josephine (Jo) Dewhurst

Josephine (Jo) Dewhurst, BSc, LLB Dip, brings over 20 years experience in clinical research to her current role as Pediatric Strategy Liaison in ICONs Centre for Pediatric Clinical Development. She has worked for a number of Clinical Research Organisations, mainly in global regulatory affairs. Her current focus is on pediatric clinical development with experience across a range of therapeutic areas and age ranges. Jo has a bachelor of science degree from the University of Glasgow and a law degree from the University of Strathclyde.

GET THE AGENDA NOW

Reasons to attend a masterclass

Practical knowledge

Venture into undiscovered territories and gain inspiration through collaboration

Interactivity

Boost your professional skills by directly engaging with domain experts

World-class trainers

Gain value and learn from the best instructors

Networking

Build a top-notch community and advance your career

Who should attend img RECOMMENDATION

Who should attend?

Clinical development professionals
Project Delivery & Management
Scientific & Medical Affairs
Clinical Trial Site personnel
Patient Engagement
Parent and Patient Advocates
Regulatory Affairs
IRB members
Academics and Researchers
Healthcare professionals

Ticket options for you

Full event
pass

Team participation?

*minimum of 10 participants

GET A QUOTE!

Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey

Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi

USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej

Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today its an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

know more >