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Medicine regulation demands the application of sound medical, scientific, and technical knowledge and skills, and operates within a legal framework.
List of contents
Section 1 Global Regulatory Perspectives of Medicinal and Pharmaceuticals ProductsChapter 1: Introduction, Challenges and Overview of Regulatory AffairsFaraat Ali, Kumari Neha, Anam Ilyas, and Hasan Ali
Chapter 2: Safety Perspectives of Medicinal ProductsRishi Kumar, Nishith Keserwani, and Parveen Kumar Goyal
Chapter 3: Regulations in the United StatesKumari Neha, Faraat Ali, Rutendo J. Kuwana, and Sharad K Wakode
Chapter 4: Regulations in the European UnionAnam Ilyas, Faraat Ali, Vishesh Sahu, and Doaa Rady
Chapter 5: Regulations in the United KingdomKumari Neha, Vivekanandan Kalaiselvan, and Faraat Ali
Chapter 6: Regulations in CanadaHasan Ali, Sandeep Kumar Singh, Babar Iqbal, Neeraj Kant Sharma, Faraat Ali, and Md. Akbar
Chapter 7: Regulations in Australia and New ZealandKumari Neha, Faraat Ali, Gaurav Pratap Singh Jadaun, and Yayra Timothy Tuani
Chapter 8: Regulations in ChinaVarisha Anjum, Khushboo Sharma, Pritya Jha, Irina Potoroko, and Rishi Kumar
Chapter 9: Regulations in IndiaArvind Kumar Sharma, Tarani Prakash Shrivastava, Meghna Amrita Singh, Jitin Ahuja, and Ramesh K. Goyal
Chapter 10: Regulations in JapanFaraat Ali, Anam Ilyas, and Shaima Ahmadeen
Chapter 11: Regulations in African Union/Southern African Region (SADC Region/ West African Region)Faraat Ali, Evans Sagwa, and Colin Shamhuyarira
Chapter 12: Regulations in Latin American CountriesTausif Alam and Irfan Ansari
Chapter 13: Regulations in ASEAN Countries Manisha Trivedi, Faraat Ali, Kumari Neha, Neelam Singh, and Anam Ilyas
Chapter 14: Regulations in Gulf Cooperation Council (GCC) Countries Usama Ahmad, Anas Islam, and Vazahat Ali
Section 2 Global Regulatory Perspectives of Food ProductsChapter 15: Introduction, Challenges, and Safety Issues of Food Regulation Leo M.L. Nollet
Chapter 16: Food Products Regulations in the European UnionVarisha Anjum, Vishal Dixit, Pritya Jha, and Irina Potoroko
Chapter 17: Food Products Regulations in CanadaFaraat Ali, Hasan Ali, and Leo M.L. Nollet
Chapter 18: Food Products Regulations in the United KingdomLeo M.L. Nollet
Chapter 19: Food Products Regulations in the United StatesLeo M.L. Nollet and Faraat Ali
About the author
Faraat Ali presently working as a Manager, Department of Inspection and Enforcement, Pharmaceutical Development Laboratory Services (Formerly National Drug Quality Control Laboratory), Botswana Medicines Regulatory Authority (BoMRA), Gaborone, Botswana. Mr Ali is a Graduate Pharmaceutical Scientist and completed Master of Pharmacy in Pharmaceutical and Medicinal Chemistry from Uttar Pradesh Technical University, India, Post Graduate Diploma in Drug Regulatory Affairs (PGDDRA) from Jamia Hamdard, India and Post Graduate Diploma in Management (PGDM) from WITS Business School, University of Witwatersrand, South Africa.
Leo M.L. Nollet earned an MS (1973) and PhD (1978) in biology from the Katholieke Universiteit Leuven, Belgium. He is an editor and associate editor of numerous books. He edited for M. Dekker, New York-now CRC Press of Taylor & Francis Publishing Group-the first, second, and third editions of
Food Analysis by HPLC and
Handbook of Food Analysis. The last edition is a two-volume book. Dr. Nollet also edited the
Handbook of Water Analysis (first, second, and third editions) and
Chromatographic Analysis of the Environment, third and fourth editions (CRC Press).
