Eva Berglund, PhDSenior Director Regulatory Strategy, Integrated Drug Development
Dr. Eva Berglund is a pharmacist by training and has a PhD in Clinical Pharmacology, both from Uppsala University, Sweden. She has been a Clinical Pharmacology reviewer at the Swedish Medical Products Agency for over 20 years and a Senior Expert for 12 years, working with all types of molecules in marketing applications, clinical trials and scientific advice procedures in the EMA Network of National agencies. Eva has been working in all therapeutic areas and has extensive knowledge in antivirals, antibiotics, CNS active drugs, oncology, rheumatology, inhalation products etc.
Eva has been Rapporteur and actively involved in drafting of several EU Clinical Pharmacology guidance documents (drug-drug and drug-food interactions, PBPK, pediatrics, pharmacogenetics, etc.), in inter-regional harmonization activities and in the work of EMA working parties Pharmacokinetics Working Party and Paediatrics Working Party. Eva joined Certara in 2019 and provides her Clinical Pharmacology experience and Regulatory strategy knowledge in GAP analyses, regulatory stress tests and moc meetings, regulatory interactions, filing and clin pharm response support, pediatric submissions (PIP, PSP, new indications). Her inspiration is scientific development and its practical application, optimizing drug development, pushing regulatory science forward, and improving patient access to efficacious and safe drugs.