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Results for tag: "Regulatory Affairs"

Implementing Risk-based Verification for Pharmaceutical Manufacturing Companies - Product Thumbnail Image

Implementing Risk-based Verification for Pharmaceutical Manufacturing Companies

  • Training
  • 90 Minutes
  • Global
The Informed Consent Process at the Investigator Site- Who decides if it is adequate and GCP compliant, Ethics Committee, Sponsor, or Investigator? - Product Thumbnail Image

The Informed Consent Process at the Investigator Site- Who decides if it is adequate and GCP compliant, Ethics Committee, Sponsor, or Investigator?

  • Training
  • 75 Minutes
  • Global
Interpreting FDA's New Guidance Document on Risk-based Monitoring - Product Thumbnail Image

Interpreting FDA's New Guidance Document on Risk-based Monitoring

  • Training
  • 60 Minutes
  • Global
When does GCP Non-compliance at an investigator site compromise a regulatory submission? To File Or Not To File - that is the question! - Product Thumbnail Image

When does GCP Non-compliance at an investigator site compromise a regulatory submission? To File Or Not To File - that is the question!

  • Training
  • 75 Minutes
  • Global
CDISC for US FDA Submissions - Are you Compliant? - Product Thumbnail Image

CDISC for US FDA Submissions - Are you Compliant?

  • Training
  • 90 Minutes
  • United States
US FDA's Pre-Approval Inspection Program - Product Thumbnail Image

US FDA's Pre-Approval Inspection Program

  • Training
  • 60 Minutes
  • United States
How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices - Product Thumbnail Image

How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices

  • Training
  • 90 Minutes
  • Global
Ethics and Scientific Misconduct in Regulated Studies - Product Thumbnail Image

Ethics and Scientific Misconduct in Regulated Studies

  • Training
  • 60 Minutes
  • Global
The U.S. FDA's New Global Engagement Initiative - Product Thumbnail Image

The U.S. FDA's New Global Engagement Initiative

  • Training
  • 90 Minutes
  • United States, Global United States, Global
Validation of Existing/ Legacy Computer Systems for FDA/EU Compliance - Product Thumbnail Image

Validation of Existing/ Legacy Computer Systems for FDA/EU Compliance

  • Training
  • 75 Minutes
  • Europe
Best Practices for Maintaining an IND and IDE Application with FDA - Product Thumbnail Image

Best Practices for Maintaining an IND and IDE Application with FDA

  • Training
  • 60 Minutes
  • Global
The 510(k) Process: Evaluating Substantial Equivalence in Premarket Notifications - Product Thumbnail Image

The 510(k) Process: Evaluating Substantial Equivalence in Premarket Notifications

  • Training
  • 60 Minutes
  • Global
Analytical Method Validation Under Good Laboratory Practices (GLPs) - Product Thumbnail Image

Analytical Method Validation Under Good Laboratory Practices (GLPs)

  • Training
  • 60 Minutes
  • Global
Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results - Product Thumbnail Image

Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results

  • Training
  • 120 Minutes
  • Global
Creating Effective SOPs for Regulatory Compliance - Product Thumbnail Image

Creating Effective SOPs for Regulatory Compliance

  • Training
  • 60 Minutes
  • Global
Effective Annual U.S. FDA CGMP Training - Product Thumbnail Image

Effective Annual U.S. FDA CGMP Training

  • Training
  • 60 Minutes
  • United States
Moving FDA Boundaries for Direct-to-Consumer Advertising - Product Thumbnail Image

Moving FDA Boundaries for Direct-to-Consumer Advertising

  • Training
  • 90 Minutes
  • Global
Prospects for Change at FDA Under the Trump Administration: Early View of What 2017 Will Bring - Product Thumbnail Image

Prospects for Change at FDA Under the Trump Administration: Early View of What 2017 Will Bring

  • Training
  • 90 Minutes
  • Global
Analytical Instrument Qualification-Understanding the New USP draft Chapter - Product Thumbnail Image

Analytical Instrument Qualification-Understanding the New USP draft Chapter

  • Training
  • 90 Minutes
  • Global
Complying with 21CFR Part 11-Understanding the Role of Predicate Rules - Product Thumbnail Image

Complying with 21CFR Part 11-Understanding the Role of Predicate Rules

  • Training
  • 60 Minutes
  • Global
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Regulatory Affairs in the biotechnology industry is the process of obtaining and maintaining approval from regulatory authorities for the development, manufacture, and marketing of biotechnology products. This includes the submission of applications, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs). Regulatory Affairs professionals are responsible for ensuring that biotechnology products comply with applicable laws and regulations. Regulatory Affairs professionals must have a thorough understanding of the regulatory environment and the ability to interpret and apply regulations to the development and marketing of biotechnology products. They must also be able to effectively communicate with regulatory authorities and other stakeholders. Companies in the Regulatory Affairs market in the biotechnology industry include Parexel, Quintiles, Covance, PRA Health Sciences, and Charles River Laboratories. Show Less Read more