Maglio & Associates focuses on:

  • “On-line” and personalized consults regarding Medical Law, professional responsibility, clinical investigation, biotechnology, medicinal drugs, clinical bioethics and investigation.

  • Elaboration of reports on regulatory affairs regarding medical praxis, medical investigation, registered medicinal drugs and administrative interventions in ANMAT, term cuts, auditing, administrative indictment at the National Direction of Personal Data Protection, representation before Justice and Health Ministries, and more.

  • Legal advising on contracts and insurance pertaining to professional practice, clinical and medical investigation (contracts between sponsors, sites and researchers, mediation, civil responsibility insurance for clinical investigation).

  • Legal sponsorship in mediation and/or legal proceedings related to clinical investigation and/or registered medicinal drugs.

  • Legal advising in legal summons ( requested reports, technical consults, and more)

  • Advising for the constitution of Teaching, Investigation and Bioethics Committees. Standardized Operative Statues and Procedures (POEs) development.

  • Permanent and immediate regulation updates of international order (FDA, EMEA, OMS, AMM, etc.), regional (OPS, UNESCO, etc.), and local (Health departments, GCBA, ANMAT, INCUCAI, etc.).

  • Regulation analysis and jurisprudence updates (national and local jurisprudence, ministerial resolutions, ANMAT dispositions, etc.)

  • Continuous training in medical responsibility in clinical investigation and medicinal drugs:
    - The importance of ethics in investigation.
    - International regulation on ethics for investigation in human beings.
    - Responsibilities of actors in clinical investigation.
    - Vulnerable populations in clinical investigation.
    - Confidentiality and Habeas Data in clinical investigation.
    - Subjects´ of investigation rights in clinical investigation.
    - Just benefits of the investigation.
    - Regulatory aspects in clinical investigation.
    - Sponsor’s responsibility in clinical investigation.
    - Monitor’s responsibility in clinical investigation.
    - International sensible data transfer in clinical investigation.
    - Legal issues in pahrmacogenetics.
    - Legal responsibility in clinical investigation and cellular therapy.
    - Informed consent in clinical investigation.
    - Informed consent in vulnerable populations.
    - Informed consent in mental health and clinical investigation.
    - Damage prevention in clinical investigation.
    - Construction and legal nature of medical documentation. Informed and electronic clinical history. Clinical history in clinical investigation. Informed and electronic CRF.
    - Conflicts of interest in the scientific findings and publication.
    - Ethics Committee’s interaction.
    - How should Ethics Committees function?

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