viii
Chapter 11 Preclinical Testing and Good Laboratory Practice Regulations. ..........................................................145
By Anu Gaur, PhD, MBA, MSRA, RAC
Chapter 12 Good Laboratory Practice Regulations................................................................................................155
By Kurt Stahl and Jennifer G. Brown, PhD, RAC
Section III: Production
Chapter 13 Manufacturing. ....................................................................................................................................169
By Andrea Armando, RAC
Chapter 14 Current Good Manufacturing Practices and Quality System Design..................................................177
By Joscelyn Bowersock, MS-RA and Richard Vincins, CQP, MCQL, CBA, CQA, RAC
Chapter 15 Canadian Good Manufacturing Practices and Establishment Licensing.............................................197
By Bocar Guisse, MSc and Fraidianie Sévigné
Chapter 16 Impact of Good Manufacturing Practices on Printed Packaging Components. ..................................215
By Debra Goetchius
Chapter 17 CMC Regulatory Strategy...................................................................................................................237
By Stephen Antonelli and Michael Craig
Chapter 18 Fundamental Principles for Labeling and Promotion of Prescription Medical Products. ....................247
By Joanne S. Hawana, MS, JD, Bethany J. Hills, MPH, JD, and Benjamin M. Zegarelli, MS, JD
Section IV: Clinical Studies
Chapter 19 Clinical Trials, Good Clinical Practice, Regulations, and Compliance.................................................295
By Anu Gaur, PhD, MBA, MSRA, RAC, Bettina Merz-Nideroest, MPharm, and Andrea Zobel, PhD
Chapter 20 Canadian Clinical Trial Applications, Good Clinical Practices............................................................313
By Mahdis Dorkalam, MSc, RHN, and Navneet Sekhon
Chapter 21 EU Clinical Evaluation and Clinical Investigations.............................................................................325
By Loes Pelgrim, MSc and Gert Bos, MSc, PhD, FRAPS
Chapter 22 Clinical Trials: GCPs, Regulations and Compliance for Drugs, Biologics and Medical Devices.........333
By Monique Carter, MS, RAC and Samantha Zappia, MS, RAC
Chapter 11 Preclinical Testing and Good Laboratory Practice Regulations. ..........................................................145
By Anu Gaur, PhD, MBA, MSRA, RAC
Chapter 12 Good Laboratory Practice Regulations................................................................................................155
By Kurt Stahl and Jennifer G. Brown, PhD, RAC
Section III: Production
Chapter 13 Manufacturing. ....................................................................................................................................169
By Andrea Armando, RAC
Chapter 14 Current Good Manufacturing Practices and Quality System Design..................................................177
By Joscelyn Bowersock, MS-RA and Richard Vincins, CQP, MCQL, CBA, CQA, RAC
Chapter 15 Canadian Good Manufacturing Practices and Establishment Licensing.............................................197
By Bocar Guisse, MSc and Fraidianie Sévigné
Chapter 16 Impact of Good Manufacturing Practices on Printed Packaging Components. ..................................215
By Debra Goetchius
Chapter 17 CMC Regulatory Strategy...................................................................................................................237
By Stephen Antonelli and Michael Craig
Chapter 18 Fundamental Principles for Labeling and Promotion of Prescription Medical Products. ....................247
By Joanne S. Hawana, MS, JD, Bethany J. Hills, MPH, JD, and Benjamin M. Zegarelli, MS, JD
Section IV: Clinical Studies
Chapter 19 Clinical Trials, Good Clinical Practice, Regulations, and Compliance.................................................295
By Anu Gaur, PhD, MBA, MSRA, RAC, Bettina Merz-Nideroest, MPharm, and Andrea Zobel, PhD
Chapter 20 Canadian Clinical Trial Applications, Good Clinical Practices............................................................313
By Mahdis Dorkalam, MSc, RHN, and Navneet Sekhon
Chapter 21 EU Clinical Evaluation and Clinical Investigations.............................................................................325
By Loes Pelgrim, MSc and Gert Bos, MSc, PhD, FRAPS
Chapter 22 Clinical Trials: GCPs, Regulations and Compliance for Drugs, Biologics and Medical Devices.........333
By Monique Carter, MS, RAC and Samantha Zappia, MS, RAC