Pediatric Clinical Drug Development
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit? Project teams, clinical teams, and study teams Individuals moving into drug development area Clinical investigators working with pharmaceutical companies
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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 Q&A sessions via chat Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com