Labelling for Prescription Drugs, Biologics and Combination Products

Eleonora Babayants
Instructor:
Eleonora Babayants
Date:
Tuesday, May 26, 2020
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 503000

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Live + Recorded
$289 $340 Live + Recorded
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$599 $680 Corporate
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Overview:

In 2019, FDA issued two guidance documents on labeling of prescription drugs, biologics and combination products. Their purpose is to make this process of labeling clearer and more helpful for patients.

The first document "Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products - Content and Format Guidance for Industry," applies to prescription drugs.

The second document "Instructions for Use - Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products - Content and Format," provides recommendations for the content and format of Instructions for Use ("IFU") documents for these products.

In this webinar, we will describe these two guiding documents, clarify confusing points, and explain how companies should comply with it. We will focus on the issues your company must consider as your company implements changes to these labels.

We will also describe the optimal structuring of the label as well as its design and layout. We will provide tips for clear written labels.

Why should you Attend: The FDA guidance documents on labeling state that holders of drug applications have an ongoing duty to ensure their labeling is accurate, and must change the content of the labeling when the existing information becomes "inaccurate, false or misleading."

In this webinar, we will describe these two guiding documents, clarify confusing points, and explain how companies should comply with it. We will focus on the issues your company must consider as your company implements changes to your labels.

We will focus on the issues your company must consider as your company implements changes to these labels. We will also describe the optimal structuring of the label as well as its design and layout. We will provide tips for clear written labels.

Areas Covered in the Session:

  • Overview of FDA guidance documents on labeling
  • Information which should be included on the label
  • Structuring the label
  • Label design and layout
  • Tips for clear written labels

Who Will Benefit:
  • Quality Assurance
  • Documentation Managers
  • Records Managers
  • Document Control
  • Compliance
  • Medical Affairs
  • IT Professionals
  • Data Managers
  • Safety Managers
  • Systems Administrators
  • Databases Administrators
  • Regulatory Affairs
  • Laboratory Managers and Supervisors
  • Production Managers and Supervisors
  • Auditors


Speaker Profile
Eleonora Babayants is a Galaxy Consulting Founder and President, She is a documentation management professional and hands-on consultant with over 25 years of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document management systems, information governance, and change management.

Eleonora's past work includes development and implementation regulatory compliance processes and procedures, leading implementation and administration of document control systems in full compliance with regulatory requirements, enabling enterprise search, improving systems information architecture, creating and implementing users training programs.

She led electronic document management systems selection and deployment, administered and supported these systems, web information portals, knowledgebase applications, recommended and implemented re-structuring of the content and the information architecture of these systems. She worked very closely with IT to do feasibility assessment and to capture users' requirements.

She wrote technical documents and created documents templates. Eleonora's experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.


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