Pediatric Drug Development: Regulatory Expectations with New Laws - Recorded Webinar

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Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Bob Kunka

OVERVIEW:
The art and science of pediatric drug development has evolved rapidly in pharmaceutical companies over the last 10 - 14 years because of the encouragement of regulatory agencies in Europe and United States.

Due to recent governmental initiatives such as the Pediatric Investigational Plans (PIPs) in Europe and the Pediatric Research Equity Act (PREA) in the United States, pharmaceutical companies have been given clear pathways and incentives to develop drug indications and products for this important group of patients. In addition to discussing the new regulations, practical and effective development approaches and study designs will also be examined.

Why should you Attend: Prescribing information was generated only in adult subjects up until European and United States governments passed laws to support pharmaceutical companies by clearly giving specific information on what the regulatory office needs to approve a pediatric indication. Additionally, adult data was able to be used to bridge to the pediatric population primarily by pharmacokinetic analysis.

Areas Covered in the Session:
- Understanding new and important laws;
- Developing a pediatric plan;
- Identify limitations of working in children and how to solve the problem;
- Utilizing adult data efficiently by including differences between adult and pediatric patients;
- Examine study designs and approaches successfully used for approval; and
- Interpret study results

Who Will Benefit:
- Project teams, clinical teams, and study teams
- Individuals moving into drug development area
- Clinical investigators working with pharmaceutical companies

SPEAKER PROFILE:
Bob Kunka Ph.D. is an accomplished and respected scientist who contributed to the development of 28 approved pharmaceutical products in eight therapeutic areas. His expertise on international product development teams produced submissions with successful clinical strategies, sound matrix management of individual study teams, and effective interactions with regulatory agencies leading to successful IND, aNDA, and NDA approvals.

Bob’s experience in drug development stems from 24 years in the pharmaceutical industry at three companies. Prior to this, he was Assistant Professor at the University of Pittsburgh where he taught undergraduate and graduate courses in pharmacokinetics. He earned his Ph.D. in pharmacokinetics at the University of North Carolina at Chapel Hill and has a B.S. in pharmacy at the University of Illinois at the Medical Center.

Bob has been consulting (The Kunka Group, Inc.) since 2008 and will be presenting at the 2014 World Congress of Basic and Clinical Pharmacology meeting in Cape Town, South Africa on July 17 as a member of a program entitled The Changing Face of Pediatric Drug Development. The title of his talk is Pediatric Drug Development from the Sponsor’s Perspective and Bridging to Relevant Data.

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