Main publications in Regulatory Sciences / Regulatory Intelligence.

Developed by Professor Dr Natália Bellan - Linkedin   LattesCNPQ  ResearchGate

Information for professional master's or PhD guidance specialized in the pharmaceutical industry

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Bellan N. Regulatory intelligence: the key to success in the modern pharmaceutical industry. Farma España Industrial. Spain, 2024, fev. pg 62-63.

Bellan N. Brief analysis of the new challenges of biotechnological products and their internationalization. Farma España Industrial. 2019, Spain, Jun 1;80-82.

Bellan N. Civil responsibility of the pharmacist in the productive chain of medicinal products. 2016. Poster session presented at 7º Simpósio Brasileiro de Vigilância Sanitária, Salvador, Brazil.

Bellan N. Guidelines for drug registration process of medicines. 2016. Poster session presented at 7º Simpósio Brasileiro de Vigilância Sanitária, Salvador, Brazil.

Bellan N. Regulatory guidelines applicable to the chain of medical devices (MDR/SAMD/MedTech). PhD thesis, University of São Paulo, Brazil, 2016.

Bellan N, de Jesus Andreoli Pinto T. Historical context of the pharmaceutical industry in Brazil. In Diretrizes no processo de regulamentação sanitária dos medicamentos no Brasil. 1 ed. Vol. 1. Sao Paulo: Editora Manole. 2015. p. 3-14.

Simonetti A, Bellan N. Sanitary intelligence and marketing tools. In Diretrizes no processo de regulamentação dos medicamentos no Brasil. Editora Manole. 2015. p. 449-455.

Bellan N. National Drug Policy. Diretrizes do Processo de Regulamentação Sanitária dos Medicamentos no Brasil. . Editora Manole, 2015. pp. 101-105.

Bellan N. Main guidelines for the sanitary registration of medicines. In Diretrizes no processo de regulamentação sanitária dos medicamentos no Brasil. 2015. p. 411-448.

Simonetti A, Bellan N. Major international and regulatory convergence institutions. In Diretrizes do Processo de Regulamentação Sanitária dos Medicamentos no Brasil. Editora Manole. 2015. p. 153-166.

Bellan N. Regulation and Regulatory Agencies. In Diretrizes no processo de regulamentação sanitária dos medicamentos no Brasil. Editora Manole. 2015. p. 10-12.

Bellan N, de Jesus Andreoli Pinto T. Sanitary regulation of medicines in Brazil: Regulamentação Sanitária dos Medicamentos no Brasil. 1 ed. São Paulo: Editora Manole, 2015. 480 p.

Bellan N, Cirilo da Silva O. Civil responsibility of the pharmacist in the supply chain of medicines. Pharmaceutical Technology. 2014 Jan 1; 1:26-29.

Bellan N, Souza Martins J. The importance of generic and similar drugs in expanding access to medicines. Revista acadêmica - Oswaldo Cruz. 2013 Dec 1;(2357-8173).

Bellan N. Guidelines for the sanitary registration process of medicines. Master's Dissertation, University of São Paulo, São Paulo, 2013. 125p.

Bellan N. Critical Analysis the Regulations Regarding the Disposal of Medication Waste. 2012. Poster session presented at I Congresso da Associação Brasileira de Ciências Farmacêuticas., Porto de Galinhas, Brazil.

Moretto L, Calixto J, Bellan N. Good Practices for Storage, Distribution and Transportation in the Pharmaceutical Industry. 1 ed. São Paulo, 2012. 137 p.

Bellan N, de Jesus Andreoli Pinto T, Mary Kaneko T, Moretto L, dos Santos Junior N. Critical analysis of the regulations regarding the disposal of medication waste. Brazilian Journal of Pharmaceutical Sciences. 2012 Jan 1;48(3):507-518.

Moretto L, Calixto J, Bellan N. Guidelines for Risk Management in Pharmaceutical Industry Processes. 1 ed. 2011. 187 p.

Professor-Advisor - Publications by postgraduate students (Specialization/MBA)

Mazucante Cyrino T, Bellan N. Analysis of European Community Post-Registration Regulation versus ANVISA. Revista acadêmica - Oswaldo Cruz. 2018 Apr 1; (2357-8173).

Mancilla Pivato S, Bellan N. Application of Risk Management in the Pharmaceutical Industry. Revista acadêmica - Oswaldo Cruz. 2017 Dec 1;(2357-8173).

Bortoloto J, Bellan N. Quality control documentation implications for drug registration approval by ANVISA. Revista acadêmica - Oswaldo Cruz. 2017 Dec 1;(2357-8173).

Francisco Souza F, Bellan N. Regulatory Framework of the Registration of Active Pharmaceutical Ingredients: Legal aspects, results obtained and perspectives. Revista acadêmica - Oswaldo Cruz. 2017 Dec 1.

Bergantini Almeida J, Bellan N. Degradation product in drugs with synthetic and semi-synthetic active substances: Brazilian regulation against the ICH. Revista acadêmica - Oswaldo Cruz. 2017 Dec 1;(2357-8173).

Zacharias Brito, Danilo; Bellan, N. Vitamin and / or mineral supplements as an opportunity for portfolio diversification by the national pharmaceutical industry. In: Revista acadêmica - Oswaldo Cruz. 2016; No. 2357-8173.

Lourenço F, Bellan N. Technology Transfer vs. Innovation. Revista acadêmica - Oswaldo Cruz. 2016 Nov 1;(2357-8173).

Ribeiro da Silva E, Bellan N. Innovative Drugs: Regulatory Challenges for Brazil. Revista acadêmica - Oswaldo Cruz. 2015 Dec 1.

Assir de Oliveira W, Bellan N. Comparative Analysis of the Registration Process of New and Generic Drugs for Human and Veterinary Use in Brazil. Revista acadêmica - Oswaldo Cruz. 2012 Jun 1;(2357-8173).

Cupertino Lentulo A, Bellan N. Judicialization of medicines and pharmaceutical assistance in the SUS. Revista acadêmica - Oswaldo Cruz. 2012 Jun 1;(2357-8173).

Carbonaro B, Bellan N. Drug Registration: Prioritizing Analysis and Innovation Opportunities. Revista acadêmica - Oswaldo Cruz. 2012 Jun 1;(2357-8173).

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