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
Lifestyle Intervention: The Quintessential tool to...
J.C Balachandar, Sanjeev Kumar Yadav, Amit Kumar Agrawal, S. Irsh...
Formulation and Evaluation of Herbal Hair Conditio...
Kaveri H. Sonawane, Gauri S. Chaure, Balu T. Jagtap, ...
Formulation and Evaluation of Ajwain soap for Anti...
Ankita R. Tandekar, Ashika A. Khursam , Ashwini B. Sarve, Priyank...
Creation And Evaluation Of Multi Herbal Fairness Cream By Using Carica Papaya An...
Manisha U. Mishra , Aishwarya A. Jain, Prachi S. Patle, Pratibha U. Thakur, Priyanshi A. Ramteke, Ri...
Development And Validation Of Bosutinib By Using UV –Spectrophotometric Method...
Vardhineedi Shirisha , R.Parasuraman, M.Poojitha, R.Gayathri, P.Mounika , M.Bheemaji, ...
Tinospora cordifolia (Giloy Or Amrita): An Updated Insight On The Multifarious P...
Saurabh Saklani , Jatin Mehra, Garima Bisht, Sanjay Rishishwar, Poonam Rishishwar, ...
Related Articles
Intellectual Property Rights...
Prajakta Pujari , Sonali Magdum, Kajal Shinde, Darshani Taral, Prajakta Chougule, Sadhana Pujari, Ra...
In Silico Studies Molecular Docking Of Novel Alkaloids As Potential Candidates F...
Aman Agarwal , Reetesh Yadav, Shagun Dubey (Upadhyay), ...
An Review On Comparative Study Of Fresh Fruit Vs Dry Fruit ...
G. M. Srimyvizhiy, K. B. Ilango, T. Geetha, S. Jayashree, S. Kaviyanchally, M. Mutharasi, A. Naveenk...
Antioxidant Therapy In Unexplained Male Infertility...
LOKESH. K, Veerammal, Yashmi Agwina Xavier , Borus Purushothaman , Suman Sharma, ...
Lifestyle Intervention: The Quintessential tool to prevent and reverse Type 2 Di...
J.C Balachandar, Sanjeev Kumar Yadav, Amit Kumar Agrawal, S. Irshad Ahamed, A. Ayeshamariam, M. Jaya...
More related articles
Lifestyle Intervention: The Quintessential tool to prevent and reverse Type 2 Di...
J.C Balachandar, Sanjeev Kumar Yadav, Amit Kumar Agrawal, S. Irshad Ahamed, A. Ayeshamariam, M. Jaya...
Formulation and Evaluation of Herbal Hair Conditioner...
Kaveri H. Sonawane, Gauri S. Chaure, Balu T. Jagtap, ...
Formulation and Evaluation of Ajwain soap for Antibacterial and Antifungal Activ...
Ankita R. Tandekar, Ashika A. Khursam , Ashwini B. Sarve, Priyanka A. Somkuwar, Anil G. Dhawade , ...
Lifestyle Intervention: The Quintessential tool to prevent and reverse Type 2 Di...
J.C Balachandar, Sanjeev Kumar Yadav, Amit Kumar Agrawal, S. Irshad Ahamed, A. Ayeshamariam, M. Jaya...
Formulation and Evaluation of Herbal Hair Conditioner...
Kaveri H. Sonawane, Gauri S. Chaure, Balu T. Jagtap, ...
Formulation and Evaluation of Ajwain soap for Antibacterial and Antifungal Activ...
Ankita R. Tandekar, Ashika A. Khursam , Ashwini B. Sarve, Priyanka A. Somkuwar, Anil G. Dhawade , ...