View Article

Abstract

In this project have given Information and regulatory documentation play inessential part in the decision-making within the company. It is particularly true in these actor of the pharmaceutical industry, in which a good risk management is essential. To find this information,to manage and to analyze, require the installation of an adapted regulatory intelligence, structured,exhaustive and relevant. Therefore, rigorous process (search of sources, data' collection, diffusion and analyze) is the necessary condition for the setting up of are regulatory environmental scanning system, as well astheadhesion of the decision makers, the collaboration of expert sand the implication of all the collaborators. This article proposes an installation diagram of a regulatory intelligence adapted to pharmaceutical industry bydetail in gets various stages until its rationing more global process of economic intelligence.

Keywords

Pharmacovigilance, Regulatory

Reference

  1. Steck O, et al. Current and emerging role of artificial intelligence in regulatory intelligence. In: Sistema W, Ashraf D, eds. Regulatory Intelligence 101. 3rd ed. Regulatory Affairs Professionals Society; 2021:179-186.
  2. Schultz M. Lessons Jack Welch taught me about being a business leader Medium website. https://medium.com/@mikeschoultz/lessons-jack-welch-taught me-about-being-a- business-leader-4589a6a383f4 Published 29 December 2015. Accessed 28 April 2021
  3. Messmer K. Background and skill set needed for a regulatory intelligence professional. In: Sistema W, Ashraf D, eds. Regulatory Intelligence 101. 3rd ed. Regulatory Affairs Professionals Society; 2021:23-32.
  4. Meredith Brown-Tu0le,RAC,Regulatorium.comtheregulatorium@gmail.com.
  5. Hazell L, Shakir SAW. Under-reporting of adverse drug reactions. Drug Save. 2006;29:385–396.
  6. https://www.google.com/url?sa=t&source=web&rct=j&url=https://capra.ca/_uploads/581ce1598d352.pdf&ved=2ahUKEwicy_GX8571AhUfUGwGHVzsB2AQFnoECBoQAQ&usg=AOvVaw3MTrBZprNW-J6Js4fha5na (www.capra.com).
  7. Www.Pda.Org(https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.pda.org/docs/default-source/website-documentlibrary/chapters/presentations/west-coast/regulatory-intelligence-101.pdf?sfvrsn=132b48e_4&ved=2ahUKEwi5z-al9J71AhWQGqYKHcEhCYsQFnoECCcQAQ&usg=AOvVaw32CwvJLCzvsPwzDlZMY6oU).
  8. Hammond sunnah (senior regulatory intelligence expert)27junewww.thombsonreuters.com(2019https://www.google.com/urlsa=t&source=web&rct=j&url=https://www.thomsonreuters.com/en-us/posts/investigation-fraud-and-risk/cost-of-compliance-survey-regulatory-change-2019/&ved=2ahUKEwjOt7vC9Z71AhXDIqYKHb2PDpIQFnoECCQQAQ&usg=AOvVaw3 ucicCglpVx8AsigXtK_TF).
  9. Raps.org Evaluation of regulatory intelligence profession posted on 29 April 2021 By Danish Ashraf dharma d and Kirsten messmer phd,RAC
  10. Hamburg MA. Innovation, regulation, and the FDA. N Engl J Med. 2010; 363(25):2228- 32.
  11. Van Grootheest K, Dukes G. Leopold Meyler (1903-1973): a pioneer in the study of adverse effects of drugs. Int J Risk Saf Med. 2003/2004;16:67-70.
  12. The importance of pharmacovigilance-safety monitoring of medicinal products. Geneva: World Health Organization; 2002. Available at:https://apps.who.int/medicinedocs/pdf/s4893e/s4893e.pdf. Accessed on 01 July 2020.
  13. Dr. V Pannikar. The Return of Thalidomide: New Uses and Renewed Concerns. WHO Pharmaceuticals News letter.2003;2. Available at: https://www.who.int/lep/research/Thalidomide.pdf. Accessed on 01 July 2020
  14. Pharmacovigilance: Ensuring the Safe Use of Medicines - WHO Policy Perspectives on Medicines,No.009, October2004. Available at:http://apps.who.int/medicinedocs/pdf/s6164e/s6164e.pdf. Accessed on 01 July 2020. WHOcc in Uppsala (UMC). Available at:https://www.who.int/medicines/areas/quality_safety/safety_efficacy/PV_fast_facts/en/.Ac cussed on 01 July 2020.
  15. Lazaro J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998;279(15):1200-5.
  16. Institute of Medicine. Preventing medication errors. 2006.Available at: http://www.iom.edu/~/media/Files/Report Files/2006/Preventing-Medication-Errors- Quality-Chasm-Series/medicationerrorsnew.pdf. Accessed on 01 July 2020
  17. Gor AP, Desai SV. Adverse Drug Reactions (ADR) in the in Patients of Medicine Department of a Rural Tertiary Care Teaching Hospital and Influence of Pharmacovigilance in Reporting ADR. Indian J . 2008:40(1):37-40.

Photo
Chaitali Bansod
Corresponding author

Nandkumar Shinde Collage of Pharmacy Vaijapur

Photo
A. K. Hatkar
Co-author

Nandkumar Shinde Collage of Pharmacy, Vaijapur

Photo
R. M. Kawade
Co-author

Nandkumar Shinde Collage of Pharmacy, Vaijapur

C. R. Bansod*, A. K. Hatkar, R. M. Kawade, Role of regulatory intelligence in pharmacovigilence, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 12, 294-306. https://doi.org/10.5281/zenodo.10369284

More related articles
Evaluation of Glycaemic Index and Insulin Index Ma...
Patole Varsha, Varade Shruti, Vadak Prachi, Zite Sonali, ...
Unwinding the Epigenetic Alterations in Progressio...
Tiyasha Mishra, Ahana Chakraborty, ...
Aegle Marmelos Peel-Off Mask: A Natural Approach t...
Samruddhi Sable , Sandip Solanke , Saniya Khan , Saurabh Kokane ,...
Phytochemical and Pharmacological Insights into Caesalpinia Bonducella: A Compre...
Rohini Jadhav, Sujata Karande, Rajnandini Kamble, Dr. D. R. Jadage, ...
The Pharmacovigilance of Digital Therapeutics (DTX): Developing A New Safety Fra...
Shantanu C. Parate, Prajwal N. Bambole, Srushti S. Padole, Sakshi N. Bawankule, Pandurang D. Biradar...
Related Articles
Formulation and Evaluation of Herbal Perfumes...
Anjali Rathod, Komal Amate, Ashwini Ujgare, Anil Muthanwad, Nandkumar Giri, Komal Bahalaskar, ...
Exploring The Therapeutic Potential Of Banaba Extract On Immobilized Restrainer ...
Swati Jadhav, Ashvini Kshirsagar, Aman Upaganlawar, Sandip Wagh, Chandrashekhar Upasani, ...
Pharmacognostical Studies and Clinical Applications of Medicinal Plants as Immun...
Himani Malode, Dr. Ajay Baitule, Gayatri Yeole , Jaydeep Wankhade, ...
Sedative And Hypnotic Activity of Stenocereus Stellatus Extract on Chronic Unpre...
Nirmal Sarda, Dr. A. M. Wankhade, Dr. V. V. Paithankar, ...
Evaluation of Glycaemic Index and Insulin Index Marketed Sugar Product...
Patole Varsha, Varade Shruti, Vadak Prachi, Zite Sonali, ...
More related articles
Evaluation of Glycaemic Index and Insulin Index Marketed Sugar Product...
Patole Varsha, Varade Shruti, Vadak Prachi, Zite Sonali, ...
Aegle Marmelos Peel-Off Mask: A Natural Approach to Skin Care with Antioxidant, ...
Samruddhi Sable , Sandip Solanke , Saniya Khan , Saurabh Kokane , Priya Dandekar , Mayuri Zore , Shi...
Evaluation of Glycaemic Index and Insulin Index Marketed Sugar Product...
Patole Varsha, Varade Shruti, Vadak Prachi, Zite Sonali, ...
Aegle Marmelos Peel-Off Mask: A Natural Approach to Skin Care with Antioxidant, ...
Samruddhi Sable , Sandip Solanke , Saniya Khan , Saurabh Kokane , Priya Dandekar , Mayuri Zore , Shi...