x
Table 9-8. International Animal Research Laws, Policies and Guidelines............................... 144
Table 9-9. Useful Web Resources for Planning and Conducting Animal Studies in
Accordance With the Three Rs’ Principles. ..............................................................145
Table 9-10. Questions a Company Should Consider When Selecting a CRO........................... 146
Table 13-1. Global Submission Planning and Prioritization Process. ........................................187
Table 13-2. Considerations for Selecting In-Country Agents. ...................................................199
Table 16-1. Example of a CV Medical Device Company Product Development Matrix .........242
Table 16-2. Country-Specific Information from the Handbook of Pharma and
MedTech Compliance.............................................................................................. 249
Table 16-3. High-Level Marketing and Advertising Information for Countries in
Asia-Pacific.............................................................................................................. 250
Table 16-4. High-Level Marketing and Advertising Information for Countries in Europe...... 251
Table 16-5. High-Level Marketing and Advertising Information for Countries in
Latin America and South America.......................................................................... 252
Table 17-1. African and Middle Eastern Regulatory Agencies .................................................264
Table 17-2. Asia/Pacific Regulatory Agencies ...........................................................................266
Table 17-3. European Commission Competent Authorities. .....................................................268
Table 17-4. Eastern European Agencies. ....................................................................................270
Table 17-5. Latin American Regulatory Agencies...................................................................... 272
Table 17-6. North American Regulatory Agencies.................................................................... 273
Table 17-7. Global Regulatory Professional Trade Organizations. ............................................274
Table 17-8. Miscellaneous Resources .........................................................................................278
Table 17-9. African/Middle Eastern Intelligence Resources. ....................................................280
Table 17-10. Asia/Pacific Intelligence Resources. ........................................................................280
Table 17-11. European Commission Intelligence Resources........................................................ 281
Table 17-12. Latin American Intelligence Resources ..................................................................282
Table 17-13. North American and Other Critical Intelligence Resources. ..................................283
Table 19-1. Summary of Select Revenue-Generating Cell Therapy Products Currently
on the Market ..........................................................................................................306
Table 19-2. Definitions of Manipulations Considered Minimal (US) or
Not Substantial (EU). ..............................................................................................307
Table 19-3. Summary of Regulatory Routes and Documents Applicable to Stem Cell and/or
Device Products. ......................................................................................................309
Table 9-8. International Animal Research Laws, Policies and Guidelines............................... 144
Table 9-9. Useful Web Resources for Planning and Conducting Animal Studies in
Accordance With the Three Rs’ Principles. ..............................................................145
Table 9-10. Questions a Company Should Consider When Selecting a CRO........................... 146
Table 13-1. Global Submission Planning and Prioritization Process. ........................................187
Table 13-2. Considerations for Selecting In-Country Agents. ...................................................199
Table 16-1. Example of a CV Medical Device Company Product Development Matrix .........242
Table 16-2. Country-Specific Information from the Handbook of Pharma and
MedTech Compliance.............................................................................................. 249
Table 16-3. High-Level Marketing and Advertising Information for Countries in
Asia-Pacific.............................................................................................................. 250
Table 16-4. High-Level Marketing and Advertising Information for Countries in Europe...... 251
Table 16-5. High-Level Marketing and Advertising Information for Countries in
Latin America and South America.......................................................................... 252
Table 17-1. African and Middle Eastern Regulatory Agencies .................................................264
Table 17-2. Asia/Pacific Regulatory Agencies ...........................................................................266
Table 17-3. European Commission Competent Authorities. .....................................................268
Table 17-4. Eastern European Agencies. ....................................................................................270
Table 17-5. Latin American Regulatory Agencies...................................................................... 272
Table 17-6. North American Regulatory Agencies.................................................................... 273
Table 17-7. Global Regulatory Professional Trade Organizations. ............................................274
Table 17-8. Miscellaneous Resources .........................................................................................278
Table 17-9. African/Middle Eastern Intelligence Resources. ....................................................280
Table 17-10. Asia/Pacific Intelligence Resources. ........................................................................280
Table 17-11. European Commission Intelligence Resources........................................................ 281
Table 17-12. Latin American Intelligence Resources ..................................................................282
Table 17-13. North American and Other Critical Intelligence Resources. ..................................283
Table 19-1. Summary of Select Revenue-Generating Cell Therapy Products Currently
on the Market ..........................................................................................................306
Table 19-2. Definitions of Manipulations Considered Minimal (US) or
Not Substantial (EU). ..............................................................................................307
Table 19-3. Summary of Regulatory Routes and Documents Applicable to Stem Cell and/or
Device Products. ......................................................................................................309