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Photo:Kristijana Milovic-Holm

Kristijana Milovic-Holm, PhD in Biochemistry / Molecular Biology
Founder and Managing Director of LITERO GmbH

Experienced Clinical Affairs and Vigilance professional with 15 years hands-on experience in the medical device and pharma industry. Skilled and experienced in development of clinical strategies and generation of clinical evidence, (pharmaco)vigilance, generation of related SOPs and regulatory authority/notified body interactions.

  • Subject Matter Expert for clinical strategies for active and non-active medical devices, Clinical Evaluation Reports (CER) and Plans (CEP), Summary of Safety and Clinical Performance (SSCP), Post-Market Surveillance (PMS) Plans/Reports, and Post-Market Clinical Follow-ups (PMCF) according to regulatory compliance (EU MDD and EU MDR).
  • Subject Matter Expert for pharmacovigilance, QPPV, Pharmacovigilance System Master File (PSMF), Periodic Safety Update Report (PSUR), Development Safety Update Report (DSUR), Signal Detection, ICSR, SUSAR according to regulatory compliance (ICH and GVP).

If you need help sorting out the clinical affairs or post-market surveillance/vigilance parts of your business, we would love to help!

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