Labeling for Prescription Drugs, Biologics and Combination Products

Instructor: Eleonora Babayants
Product ID: 706502
  • 3
  • September 2020
  • 07:30 AM PDT | 10:30 AM EDT
    Duration: 60 Min
In 2019, FDA issued two guidance documents to ensure that FDA-approved labeling provides clear and complete information and to prevent the potential for abuse on how drugs or biologics are used. These guidance documents reflect the FDA’s efforts to ensure that both health care professionals and patients have up-to-date, accurate and actionable information about prescription drugs to inform treatment decisions. It is important for companies to learn these new guidance documents so that the new rules could be applied to labels creation.

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September 03, Thursday 07:30 AM PDT | 10:30 AM EDT | Duration: 60 Min

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Read Frequently Asked Questions

Why Should You Attend:

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.

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 Webinar:

  • 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

From Regulated industries such as Pharmaceutical, Medical Devices, Food, Cosmetics, any other regulated industry and not regulated industries; any industry

Free Materials:

  • Presentation
Instructor Profile:
Eleonora Babayants

Eleonora Babayants
Founder and President, Galaxy Consulting

Galaxy Consulting Founder and President Eleonora Babayants has many years of GxP/GMP hands-on experience in regulated industries. She worked with quality assurance and compliance officers to develop and execute compliance strategies and programs. She participated in the implementation of compliance requirements.

Her many years’ experience includes regulatory compliance, internal and external auditing, change management, documentation and records management, document control, electronic document management systems, information governance, IT systems management and validation.

Eleonora’s past work includes development and implementation of regulatory compliance policies, processes, and procedures, leading implementation and administration of document control and document management systems in full compliance with regulatory requirements, designing and implementing electronic documents workflows, leading enterprise content management initiatives, enabling enterprise search, improving systems information architecture, creating and implementing users’ training programs.

Eleonora ensured document management systems compliance with regulatory requirements. She collaborated with users to develop positive and productive approaches to regulatory compliance, coordinated, prepared, and participated in internal and external audits including FDA audits.

Eleonora’s experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.

Follow us :
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions
Change Control Best Practices - Avoiding Unintended Consequences of Changes

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