Promotion of Biomedical Products: Regulatory Considerations
Available
Examines advertising, labeling and promotion regulations.

Regulation of Combination Products
Available
This course examines the current regulations and policies covering the identification, jurisdiction and review of combination products in the US. It covers premarket activities, applicability of Good Manufacturing Practice (GMP) and postmarket requirements, such as adverse event reporting, inspection and enforcement.

Biologics Development: A Regulatory Overview, 3rd Edition
Available
Provides a comprehensive review of FDA’s regulation of biologic products.

Biopharmaceuticals: Biochemistry & Biotechnology
Available
Provides a comprehensive review of the latest developments in the biopharmaceutical industry.

The Challenge of CMC Reg Compliance for Biopharmaceuticals
Out of Stock
Covers how to manage chemistry, manufacturing and controls (CMC) regulatory compliance requirements for biopharmaceuticals.

Guidebook to Better Medical Writing
Available
Filled with examples, checklists, step-by-step directions, tips, techniques and authoritative advice on medical writing.

Expediting Drug & Biologics Development
Available
How to use reverse-engineering techniques to drive and improve a development program.

CE Conformity Marking and New Approach Directives
Available
This book explains the meaning, history, requirements and effects of CE Marking

Preclinical Safety Evaluation of Biopharmaceuticals
Available
This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses.

Effective Communication & Negotiation
Available

This course provides a basic understanding of the use of effective skills for all regulatory communications, from influencing teams and negotiating to everyday activities within and across the company.