Pediatric Development and Recent Laws
Compliance4All announces webinar on the topic, “Pediatric Development and Recent Laws” on October 26. This webinar will explain the recent US and European regulations aimed at offering practical and effective development approaches to study designs recommended for developing indications and products for pediatric patients.
Fremont, CA: Compliance4All, a provider of cost-effective regulatory compliance trainings for a wide range of regulated industries, will organize a webinar on October 26. The topic of this webinar is “Pediatric Development and Recent Laws”, and the speaker is Robert Kunka, President & Clinical Drug Development and Approval Process Consultant, The Kunka Group, Inc.
About the webinar:
Till the last 10-14 years, prescribing information was generated only in adult subjects. Also, adult data was used as a bridge to the pediatric population primarily by pharmacokinetic analysis. Of late, all that has changed.
For more information or to register for the webinar, please click here.
The recent passage of laws by European and US governments support pharmaceutical companies by clearly giving specific information on what the regulatory office needs if it has to approve a pediatric indication. As a result of these laws and due to the encouragement of regulatory agencies in Europe and United States; there has been a rapid change in the art and science of pediatric drug development in pharmaceutical companies over this period of time.
Recent governmental initiatives such as the Pediatric Investigational Plans (PIPs) in Europe and the Pediatric Research Equity Act (PREA) in the United States have given clear pathways and incentives for pharmaceutical companies to develop drug indications and products for the pediatric group of patients.
This webinar will discuss the details and implications of these new regulations. In addition, the speaker will also explain practical and effective development approaches and study designs.
About the Speaker:
Robert Kunka, Ph.D., is President & Clinical Drug Development and Approval Process Consultant, The Kunka Group, Inc. Dr. Kunka is an accomplished and respected scientist who contributed to the development of 28 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.
About Compliance4All:
Compliance4All (http://www.Compliance4All.com/) is a specialized offering from NetZealous, a Fremont, CA-registered organization. It is a source for a wide range of professional trainings, compliance trainings and consulting for the regulated industries. Compliance4All offers a broad range of high quality, affordable regulatory and compliance-related services relating to medical devices, pharmaceutical, FDA, clinical trials, laboratory compliance, biologicals, drugs, food and biotechnology.
Many professionals in the various areas in which Compliance4All offers its trainings have benefited from the vast experience of its well-known speakers, who are reputed globally in their respective fields.
Contact information:
Call: 1-800-447-9407;
Visit: http://www.netzealous.com/
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