Raleigh, NC, Oct. 27, 2011 - INC Research, LLC, a therapeutically focused clinical research organization (CRO) with a Trusted Process® for delivering reliable results, today announced the launch of its complimentary educational Pediatric Webinar Series “The Classroom – Sharing the Lessons of Successful Pediatric Strategies” designed for global pharmaceutical and biotechnology companies interested in the latest best practices for conducting successful pediatric clinical trials. The first webinar, “Navigating Pediatric Regulations in the United States and European Union,” will take place Tuesday, Nov. 8 at 10 a.m. EST/3 p.m. GMT.
The FDA and EMA’s requirement of pediatric plans for new active ingredients, dosage forms, dosing regimens or routes of administration has made a thorough understanding of such regulations essential. In fact, without a “Paediatric Investigation Plan” (PIP), the EMA will no longer validate any submission. In the Nov. 8 session, Klaus Rose, MD, MS, Managing Director, klausrose Consulting, and William Sietsema, PhD, Vice President, Global Regulatory Strategy, Consulting and Submissions, INC Research, will share their advice on how to create insightful and innovative pediatric strategies that meet these stringent regulatory requirements in a one-hour interactive session.
“Over the past 10 years we’ve seen a significant rise in the number and scope of pediatric clinical trials as a result of legislation within the United States and European Union promoting and requiring pediatric research as a part of the drug development process,” said Kathryn Bohannon, Principal Strategist, Pediatrics, INC Research. “INC Research has developed this webinar program to support our customers and help biopharmaceutical companies increase their awareness of the need for pediatric-specific research. Children are not merely little adults when it comes to trial design and execution.”
The second webinar, “Pediatric Clinical Trials – Lessons Learned the Hard Way,” is scheduled for Tuesday, Dec. 13 at 10 a.m. EST/3 p.m. GMT and will feature Gregory L. Kearns, PharmD, PhD, Marion Merrell Dow/Missouri Chair in Pediatric Medial Research and Alexander Cvetkovich Muntañola, MD, Senior Director, Clinical Development, INC Research. Dr. Kearns and Dr. Cvetkovich Muntañola will discuss the common mistakes drug developers make in the design and execution of early phase pediatric trials and how to avoid them.
INC Research’s Pediatric Webinar Series will move to a quarterly schedule in 2012 and will feature expert panelists who have specialized in pediatric clinical trials and understand the nuances of designing and executing a clinical trial for neonates, infants, children and adolescents. Topics will range from parental permission and pediatric assent, global trial design, regulatory and medical challenges to dosing and safety issues and the ethics and logistics for pediatric research. Anyone involved in the design and execution of clinical development programs is encouraged to attend.
INC Research’s pediatric team has completed more than 250 pediatric studies and consulting projects involving more than 60,000 patients and 5,000 sites since 2005. The Company’s experience spans all pediatric age groups and all geographies and a diverse set of indications within respiratory/allergy diseases, hemato-oncology, CNS, endocrinology, infectious diseases, metabolic diseases, vaccines and more. For more information on INC Research’s pediatrics capabilities, click here.
To register for INC Research’s complimentary pediatric clinical trial webinars hosted by Xtalks, please click here.
About INC Research, LLC
INC Research is a therapeutically focused clinical research organization with a high-performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I through Phase IV programs in all therapeutic areas and innovative pediatric and women’s health trials. The Company’s Trusted Process® methodology and therapeutic foresight lead customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, NC. For more information, please visit www.incresearch.com
