Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions

Author:

Ball Greg1ORCID,Kurek Raffael2,Hendrickson Barbara A.3,Buchanan James4,Wang William W.5,Duke Susan P.6,Bhattacharyya Amit7,Li Mengchun8,O’Brien Dennis9,Weigel Judith10,Wang Wenquan11,Jiang Qi12,Ahmad Faiz13,Seltzer Jonathan H.14,Herrero-Martinez Esteban15,Tremmel Lothar16

Affiliation:

1. Clinical Safety Statistics, Merck Research Laboratories, Rahway, NJ, USA

2. Global Patient Safety, Eli Lilly and Company, Windlesham, UK

3. Pharmacovigilance and Patient Safety, AbbVie, North Chicago, IL, USA

4. Covilance LLC, Belmont, CA, USA

5. Clinical Safety Statistics, Merck Research Laboratories, North Wales, PA, USA

6. Office of Biostatistics, Center for Drug Evaluation, Food and Drug Administration, Silver Spring, MD, USA

7. Biometrics, ACI Clinical, Bala Cynwyd, PA, USA

8. Global Alliance for TB Drug Development, New York City, NY, USA

9. Risk Management, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA

10. Pharmacovigilance, vfa Research-Based Pharmaceutical Companies, Berlin, Germany

11. Biostatistics, Sanofi Pasteur, Swiftwater, PA, USA

12. Biometrics, Seattle Genetics, Bothell, WA, USA

13. US Biostatistics, Galderma R&D, Fort Worth, TX, USA

14. ACI Clinical, Bala Cynwyd, PA, USA

15. Regulatory Policy and Intelligence, AbbVie, Maidenhead, UK

16. Biostatistics and Medical Writing, CSL Behring, King of Prussia, PA, USA

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

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