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Pediatric Clinical Studies for Pharmaceutical and Medical Device Products Conference
Pediatric Clinical Studies for Pharmaceutical and Medical Device Products Conference

Our Price: $495.00

Product Code: 2323

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About the Product
Includes presentation materials from the conference. Presentations slides are in PDF. format. All files are available for immediate download.

About the Pediatric Clinical Studies for Pharmaceutical and Medical Device Products Conference:

Development of Safe & Effective Therapies for Pediatric Populations through the Implementation of Innovative Clinical Study Design, Streamlined Recruitment & Retention through Partnerships with Families, & Strict Adherence to Evolving PIP, PSP and International Pediatric Regulatory Frameworks.

Throughout the life sciences industry, manufacturers are conducting valuable research and development of therapies and technologies that will ultimately enhance the health and safety of pediatric patient populations throughout the world, through clinical studies that support the safe and appropriate use of products. Although clinical studies for pediatric populations share a similar structure with those conducted in adults, the challenges are compounded by logistical, regulatory and ethical barriers established to safeguard the vulnerable pediatric population. Overcoming these barriers is essential to the development of new therapies for pediatric populations, and the Q1 Pediatric Clinical Research Conference will provide clinicians, ethicists and regulatory executives with an opportunity to discuss the evolution of pediatric research best practices in an environment driven by the shared goal of the development of safe and effective pediatric therapies.

Presenter perspectives will draw on a wide variety of stakeholders in the industry, including pharmaceutical, biotechnology, medical device and diagnostic corporations, in addition to regulators including the FDA and government agencies such as the NIH, all of which play an important role in pediatric drug development. Topics addressed will cover changes to regulations including Pediatric Investigation Plans, Pediatric Study Plans, new ICH regulations impacting pediatric research, as well as the ongoing evolution of international regulations, with a focus on the EU, China and India. Case study sessions by industry veterans will also provide unique insights into the conduct of specific therapeutic area studies, focusing on the challenges presented by neonatal research, oncology drug development, as well as the use of pain medication in children. Throughout, presenters will share best practices, engaging the audience to discuss the development of a robust pediatric clinical trial network where organizations can support the shared goal of working safely and effectively with pediatric patients.

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