ComplianceOnline

Expert Profile


Karl M. Nobert
Attorney,

Karl M. Nobert is an accomplished attorney with expertise in the U.S. Food and Drug Administration’s regulation of prescription and over-the-counter drug products, food, biologics, medical devices and veterinary products. Mr. Nobert possesses a considerable understanding of and experience dealing with the FDA’s regulation of human and veterinary regenerative medicine including the marketing and sale of stem cell-based products intended for human use. He frequently presents and has published on the subject, and currently services as Legal Advisor to the "International Veterinary Regenerative Medicine Society”

Trainings by Expert

An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use
Category: Drugs and Chemicals (Pharma) , Biotechnology , Quality & Safety , Tissue and Tissue Products , Cellular and Gene Therapy , Biotech Regulations , Regulations & Guidances , Life Sciences , Regulatory Affairs

3-hr Virtual Seminar - Regenerative Medicine: An Introduction to FDA's Regulation of Cell Therapies and HCT/Ps Generally
Category: Biotechnology , Tissue and Tissue Products , Cellular and Gene Therapy , Life Sciences

3-hr Virtual Seminar: An Introduction to the FDA New Drug Approval Process
Category: Drugs and Chemicals (Pharma) , Quality and Safety , Supply Chain and Manufacturing , Drugs Regulations , Regulations & Guidances , Life Sciences , Regulatory Affairs

The U.S. Food and Drug Administration’s Regulation of Pet Food: Complying with FDA’s Rules for the Marketing and Sale of Dog and Cat Food
Category: Packaging and Labeling , Food Safety Compliance , Food & Dietary Supplements , Manufacturing & Contamination control , Regulatory Affairs

FDA's Oversight of Mobile Medical Applications (''apps'') for Use on Smartphones and Similar Mobile Devices
Category: Medical Devices , Marketing and Promotion , R & D , Research & Development , Device R & D , Life Sciences , Documentation and Data Management

3-hr Virtual Seminar: FDA Medical Device Regulation for the Beginner
Category: Medical Devices , Life Sciences , Documentation and Data Management

FDA's Regulation of Veterinary Regenerative Medicine: What Industry Needs to Know to Market and Sell a Stem Cell Product for Use in Dogs, Cats, Horses and other Animals
Category: Drugs and Chemicals (Pharma) , Biotechnology , Documentation and IT , Quality & Safety , Tissue and Tissue Products , Cellular and Gene Therapy , Biotech Regulations , Regulations & Guidances , Life Sciences , Regulatory Affairs

Making Sense of FDA's (proposed) Rules for the Development and Approval of Biosimilars
Category: Biotechnology , Quality , Testing and Validation , Biologics and Biosimilars , Biotech Regulations , Regulations & Guidances , Life Sciences , Regulatory Affairs

An Introduction to FDA's Regulation of Over-the-Counter (OTC) Drug Products
Category: Drugs and Chemicals (Pharma) , Quality and Safety , Audits & Inspections , Audit & Inspection-Role , Drugs Inspections , Life Sciences

Medical Foods: Understanding what Constitutes a Medical Food for FDA Regulatory Purposes and Strategies for Successfully Commercializing such Products in the U.S.
Category: Drugs and Chemicals (Pharma) , Clinical Research , Packaging and Labeling , Food Safety Compliance , Drug Marketing Compliance , Quality and Safety , Drug Development , Food & Dietary Supplements , Manufacturing & Contamination control , Clinical Trial Regulations , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management