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The Clinical Development Process: Investigational Product, Plan, and Data Management

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Overview 

A UL EduNeering course

This course covers the process of developing a research protocol for human investigation and testing for medications that are not sold or available in the United States. This process requires recruiting and enrolling people to participate as volunteers in an investigational study for a new product not currently sold. In this course, such studies are referred to interchangeably as “clinical research trial” and “investigational study.” This course outlines the steps that must be taken by a sponsor of a new drug or product before it is available for sale. Discussions will include steps required for the investigational drug approval process and device clinical trials (device trials with human subjects).

Featured Topics 

  • Requirements for financial disclosure
  • Who is responsible for disclosing financial information
  • How FDA evaluates clinical investigators’ financial disclosures

Who Should Attend 

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

Special Offers 

Save by purchasing multiple UL EduNeering eLearning modules at one time. One to two modules cost $99 each, three to four cost $89 each, five to nine cost $80 each, and 10 or more cost $65 each.

Contact Information 

Linda Belmont, DIA
Phone +1.215.293.5818
Linda.Belmont@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Registration Fees 

Other Fees

Individual
$99.00
Group Discounts

When purchasing multiple UL EduNeering eLearning modules in one transaction, the following discount prices apply:

·          1 to 2 modules are $99.00 each

·          3 to 4 modules are $89.00 each

·          5 to 9 modules are $80.00 each

·          10 or more modules are $65.00 each

Register Online
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