INC Research, LLC, a therapeutically focused clinical research organization (CRO) with a trusted process for delivering reliable results, has announced the launch of its complimentary educational paediatric webinar series “The Classroom – Sharing the Lessons of Successful Paediatric Strategies” designed for global pharma and biotech companies interested in the latest best practices for conducting successful paediatric clinical trials. The first webinar, “Navigating Paediatric Regulations in the US and EU,” will take place on November. 8 at 10 a.m. EST/3 p.m. GMT.

The US FDA and EMA's requirement of paediatric 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 November 8 Session, Klaus Rose, Managing Director, Klausrose Consulting, and William Sietsema, Vice President, Global Regulatory Strategy, Consulting and Submissions, INC Research, will share their advice on how to create insightful and innovative paediatric 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 paediatric clinical trials as a result of legislation within the United States and European Union promoting and requiring paediatric research as a part of the drug development process,” said Kathryn Bohannon, Principal Strategist, Paediatrics, INC Research. “INC Research has developed this webinar program to support our customers and help biopharmaceutical companies increase their awareness of the need for paediatric-specific research. Children are not merely little adults when it comes to trial design and execution.”
 
The second webinar, “Paediatric Clinical Trials – Lessons Learned the Hard Way,” is scheduled for Tuesday, December 13 at 10 a.m. EST/3 p.m. GMT and will feature Gregory L. Kearns, PharmD, PhD, Marion Merrell Dow/Missouri Chair in Paediatric 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 paediatric trials and how to avoid them.
 
INC Research’s paediatric webinar series will move to a quarterly schedule in 2012 and will feature expert panelists who have specialized in paediatric 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 paediatric assent, global trial design, regulatory and medical challenges to dosing and safety issues and the ethics and logistics for paediatric research. Anyone involved in the design and execution of clinical development programmes is encouraged to attend.
 
INC Research’s paediatric team has completed more than 250 paediatric studies and consulting projects involving more than 60,000 patients and 5,000 sites since 2005. The company’s experience spans all paediatric 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.