Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

1. Developing a target
Linda Fossati Wood

2. Regulatory writing tips
Linda Fossati Wood

3. Templates and style guides: The nuts and bolts of regulatory documents
James Yuen, Debra L. Rood

4. Document review
Linda Fossati Wood, MaryAnn Foote

5. Protocols
Linda Fossati Wood

6. Clinical study reports
Linda Fossati Wood

7. Investigator’s brochures
Linda Fossati Wood

8. Investigational medicinal products dossier
Linda Fossati Wood

9. Integrated summaries of safety and efficacy
Jennifer A. Fissekis

10. Informed consent forms
Jennifer A. Fissekis

11. Global submissions: The common technical document
Peggy Boe

12. Clinical trial procedures and approval processes in Japan
Takumi Ishida, Katsunori Kurusu

13. Region-specific submissions: United States of America
Linda Fossati Wood

Keywords: TECHNOLOGY & ENGINEERING / Biomedical TEC059000