Individual
location
Flexible
date

A 2-day practical & interactive training:

Regulatory requirements
in the US

Equip your professionals with the basis of the regulatory requirements in the US. Delegates will gain an insight into important guidelines, legislation, variations submissions, CBEs, annual reports, third party distributors and the FDA.
Regulatory requirements in the US

Agenda

DAY 1

Important guidelines and legislation
  • Regulatory requirements in the US
  • Third party distributors / private labellers
  • Variations submissions / deficiency letters
  • Identify each of the labelling elements
  • Examples of different products and labelling changes
  • Risk based approach
  • Product and process understanding
  • Critical attributes and parameters
  • Continuous improvement
  • Fewer changes and supplements

Variations submissions / deficiency letters
  • When should variations be submitted
  • The variability of the requirements for different product types
  • Timelines
  • The variation approval process
  • Influencing cost and number of variations, user fees

Annual reports
  • What to include and how to build a reply
DAY 2

Pharmacovigilance requirements
  • The differences between the EU and the US

Third party distributors / private labellers
  • Interfacing with vendors
  • Important contracts and agreements
  • Qualiy issues and auditing
  • Change control

Drug Establishment Registration and listings
  • General requirements for Drug Establishment Registration (DER)
  • Maintenance and general requirements for drug listing of API and DP

Working with the FDA Website
  • How to retrieve relevant information
  • Guided tour through the website
After every session a case study will show how theory works in practice.
Book this training

Please contact us to arrange your individual setup (date, location, agenda):

Contact us via web formular

+43 (0)1 890 57 14