
Luciano Alcobia
Research Assistant Intern

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About me
PharmD | Regulatory Affairs at Novartis
Education

Universidade do Algarve
2017 - 2022MSc Pharmaceutical SciencesMaster Thesis: Regulatory Aspects of the Marketing Authorization of Medicines Used in the Treatment and Prevention of COVID-19. Final Grade: 19/20.

Faculdade de Direito da Universidade de Lisboa
2022 - 2022Postgraduate Degree Health and Medicine's Law and EconomicsTopics:- Regulatory Affairs;- Health Economics;- Market Access;- Ethics;- Clinical Trials. Final work: Regulatory Framework in the Medicine Field: Current and Future Perspectives.
Experience

International Institute for Research and Innovation on Ageing (4ie)
Mar 2019 - Jul 2020Research Assistant InternConstruction of a Cross-Border Pharmacogenetic Factors Database, under the Interreg program, in collaboration with the Universities of Évora (Portugal) and Extremadura (Spain). • Introduction to pharmacogenomics, pharmacogenetics, and biomarkers;• Responsible for the pharmacogenetic data analysis for the respiratory and systemic hormonal preparations systems based on the SmPCs;• Biomarkers analysis and evaluation;• Bibliographic research;Article published at BMC Psychiatry: https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-022-04225-2#Sec12 Show less

Regional Pharmacovigilance Unit of Algarve and Baixo Alentejo
Jun 2021 - Nov 2021Pharmacovigilance Assistant Intern• Responsible for the processing of notifications of ADRs and follow-up of specific cases;• Analysis of international guidelines, orientation guides, and current legislation;• Construction of case narratives;• Introduction and analysis of MedDRA dictionary, Portal RAM, Eudravigilance, and Vigilyze;• Introduction, validation, and harmonization of UFALBA's data;• Participation in several pharmacovigilance training and workshops;• Bibliographic research.

Uniwersytet Jagielloński-Collegium Medicum
Jul 2021 - Aug 2021Research Assistant InternResearch internship in the Bromatology Department:• Preparation and manipulation of chemical and biological samples;• Extraction of essential oils of Goji seeds - phytochemistry lab work:• Use of Inductively Coupled Plasma Mass Spectrometry and Flame Atomic Absorption Spectroscopy techniques;• Observation of the Clinical Trials process at the university research unit.

CHLO,EPE
Mar 2022 - Apr 2022Hospital Pharmacy Intern• Elaboration of pharmacokinetics protocols; • Creation of oncology drug reports for the Pharmacy and Therapeutic Commission (CFT);• Assistance in the management of narcotics and blood derivatives products;• Notification of Adverse Drug Reactions (ADRs) to the pharmacovigilance unit;• Hospital pharmacy management;• Clinical pharmacology;• I took part in a translational research course.

A Minha Farmácia
May 2022 - Aug 2022Community Pharmacy Intern• Backoffice assistance;• Patient counseling;• Biochemical parameters monitoring;• Pharmacy management.

Johnson & Johnson Innovative Medicine
Sept 2022 - Dec 2023• Assisted with the marketing authorization of a new oncology drug - revision, translations of texts, and lifecycle management operations• Enrolled in a project to optimize a tool used by the Regulatory Affairs and Commercial Quality Teams• Supported preparation and submission of Marketing Authorization variations• Supported translation and review of labeling documents• Supported the process of development and implementation of packaging materials• Supported preparation of responses to requests for information• Supported preparation and participation of internal audits related to regulatory activities• Managed promotional materials documentation and samples archives• Archived all regulatory relevant documentation Show less
Medical Information Administrator
Sept 2023 - Dec 2023Regulatory Affairs & Medical Information Trainee
Sept 2022 - Oct 2023

Novartis
Jan 2024 - nowRegulatory Affairs Postgraduate - Early Development
Licenses & Certifications
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Good Clinical Practice
The National Institute on Drug Abuse (NIDA)Apr 2023
43rd EPSA Annual Congress Lyon France
EPSA - European Pharmaceutical Students' Association
Honors & Awards
- Awarded to Luciano AlcobiaWinner of the 2021 Edition of the Portuguese Pharmaceutical Sciences Olympics Associação Portuguesa de Estudantes de Farmácia Dec 2021 This Edition included the Marketing Challenge, Industry Skills Event, and Patient Counseling Challenge.
Volunteer Experience
Head of International Relations Department: Liaison Secretary & National IMP Coordinator
Issued by Associação Portuguesa de Estudantes de Farmácia - APEF on Dec 2020
Associated with Luciano AlcobiaCoordinator of the International Relations Department
Issued by NECiFarm UAlg on Dec 2018
Associated with Luciano AlcobiaCollaborator of the Cultural Department
Issued by NECiFarm UAlg on Dec 2017
Associated with Luciano Alcobia
Languages
- poPortuguês
- inInglês
- itItaliano
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