4th Pediatric Clinical Trials

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Dear Colleagues,

It is with great pleasure that I invite you to the 4th Pediatric Clinical Trials Conference: Successfully Balancing Regulatory Requirements While Designing and Conducting Effective Pediatric Clinical Studies.

The development of new medications for children is a rapidly expanding area of pharmaceutical research. While this growth has occurred partly in response to evolving regulatory requirements by the FDA in 1997 and the EMA in 2007, the development of more marketed drugs for children is a societal imperative.

The successful conduct of pediatric trials involves an in-depth understanding of current regulatory mandates as well as clinical, operational, ethical, and legal challenges. Furthermore, the incorporation of pediatric clinical research into an overall organizational framework for drug development can be equally as daunting.

In response to the increased pressure to conduct clinical trials in children, this forum will serve to provide a foundation for the successful implementation of pediatric trials. Key industry and academic experts will address the unique concerns raised by ethics committees, investigators, and parents surrounding the conduct of clinical trials in children and will provide strategies for incorporating a pediatric clinical program into an existing global clinical trials paradigm.

Please join us for in-depth discussion and a shared learning opportunity.

Sincerely,
Julie A. Rosenberg, MD
Director, Oncology Global Clinical Research
Bristol Myers-Squibb 

At this conference, you will:

  • Learn how to submit PIP plans and work with regulatory agencies to gain approval and real challenges to deferrals and waivers
  • Translate PIP plans into global clinical trials that include both US and EMA requirements
  • Evaluate challenges in finding partners and uncover new ways to better prepare clinical sites for pediatric trials
  • Discover innovative strategies of pediatric recruitment and
  • Incorporate external partners early to the design process to form the most valuable and robust pediatric trials

 

Who Should Attend

Professionals from Pharmaceutical, Biotechnology and Medical Device companies with responsibilities in the following areas:

  • Clinical Operations
  • Clinical Development
  • Regulatory Affairs
  • Translational Medicine
  • Pediatric/ Paediatric/Perinatal
  • Drug Development
  • Clinical Research
  • Clinical Project
  • Trial Management
  • R&D Operations
  • Drug Safety
  • Project Management
  • Clinical Trial Management
  • Medical Affairs
  • Clinical Affairs
  • Pharmacovigilance
  • Pharmacology


This event is also of interest to:

  • CROs specializing in pediatric studies
  • Patient Recruitment Firms
  • Consultants who can assist in the PIP scripting process and trial design
  • Regulatory firms working in trial design