Pediatric Clinical Drug Development

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• Pediatric Clinical Drug Development

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• Instructor Profile
• Bob Kunka is an acclaimed
  scientist who has a long history of getting drug
  approvals quickly. The secret of this success is
  the fusing of his broad and deep experience in
  drug development over a number of therapeutic
  areas and an intuitive approach to problem
  solving.
• As co-inventor of the Advair HFA patent in
  2007, Bob demonstrated that reduced systemic
  exposure leading to the potential for improved
  safety was possible while maintaining efficacy.
  His understanding of regulatory needs resulted in
  the timely FDA approval of a number of products
  and makes him a valued member of any drug
  development team. Bob is the founder of The
  Kunka Group, Inc., a consulting company providing
  drug development expertise to the pharmaceutical
  industry. 

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• Description
• Pediatric clinical drug development has
  evolved
• rapidly in pharmaceutical companies over the last
  
• few years because of the encouragement of
• regulatory agencies in the United States (US) and
  
• Europe. Due to recent governmental initiatives
  such
• as the Pediatric Research Equity Act (PREA) in
  the US
• and Pediatric Investigation Plans (PIPs) in
  Europe,
• pharmaceutical companies have been given clear
• pathways and incentives to develop drug
  indications
• and products for this important group of
  patients.
• This webinar will discuss the regulations
  that
• support this initiative, practical and effective
• development approaches, and study designs.

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• Why Should you Attend?
• Prescribing information
  was generated in adult subjects until European
  and United States governments passed laws to
  support pharmaceutical companies. Thus,
  physicians' extrapolated pediatric doses from a
  different population resulted in doses that were
  often inaccurate leading to toxicity and/or
  therapeutic activity. However, over the last few
  years development of drugs for children has
  progressed due to the initiatives of European and
  United States governments. 

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• Objectives of the Presentation
• The objectives of the presentation are
• Understanding the new laws
• Identifying limitations of working in children
• and how to solve the problem
• Utilizing adult data efficiently by including the
• differences between the two populations.
• Developing a pediatric plan
• Examining study designs and approaches
• successfully used for approval
• Interpreting the study results

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• Who can Benefit?
• Project teams, clinical teams, and study teams
• Individuals moving into drug development area
• Clinical investigators working with
  pharmaceutical companies

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• Recorded Session - How it works?
• A link will be provided to you upon purchase of
  the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf format will be
  mailed to you
• Get certification of attendance.
• Live Session - How it works?
• Username and Password will be sent to you 24
  hours prior to the webinar
• Presentation handouts in pdf format will be
  mailed to you
• Login to the session using the username and
  password provided to you
• Get answer to your queries through interactive
  QA sessions via chat
• Get certification of attendance.

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• Get Connected With Us

www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com