and personalized consults regarding Medical Law, professional
responsibility, clinical investigation, biotechnology, medicinal
drugs, clinical bioethics and investigation.
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
for the constitution of Teaching, Investigation and Bioethics
Committees. Standardized Operative Statues and Procedures (POEs)
and immediate regulation updates of international order (FDA,
EMEA, OMS, AMM, etc.), regional (OPS, UNESCO, etc.), and local
(Health departments, GCBA, ANMAT, INCUCAI, etc.).
analysis and jurisprudence updates (national and local jurisprudence,
ministerial resolutions, ANMAT dispositions, etc.)
training in medical responsibility in clinical investigation
and medicinal drugs:
- The importance of ethics in investigation.
- International regulation on ethics for investigation in human
- 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
- 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?