Igor Popovic, Phd Email & Phone Number

7 Allée Kastner, 67000 Strasbourg, France

Manage resources of the section and monitoring progress towards goals.Scientific assessment of CMC data related to applications for CEPs in accordance with relevant rules and guidelines

7 Allee Castner,Fr-67081 Strasbourg, France

Scientific assessment of new applications for certificates of suitability to Ph.Eur monograph.

Allocate, coordinate and conduct monitoring of CMC assessment projects during marketing authorizations, renewals, and variations. Prepare plans and reports of pharmaceutical department, actual vs. forecasting.As of 10/2013 appointed by EDQM as assessor for the chemical purity in CEP procedure.

1. Assess the quality of medicinal products during marketing authorization granting and authorization renewal and variations.2. Take part in evaluation of SmPC (Summary of Product Characteristics) and PIL (Patient Instructions Leaflets).3. The performing duties assigned by manager in terms of conducting ICH regulations, directives, guidelines, regulations in valid Pharmacopoeias (Ph. Eur., BP, USP).

1. The quality control of medicines for human use and quality control of herbals.2. The preparing laboratory reports regarding the assessment of dossier for medicines during marketing authorization process.3. The member of group for implementation of ISO 17025 standard, as well as group for maintenance ISO 9001 and ISO 14001 standards. 4. The assessment certificates of conformity (analysis) for imported batches – manufacturers outside of Serbia.

Quality control (QC) of medicines for human use as well as QC of herbal preparations (e.g. performing tests concerning identification, assay, impurities of pharmaceutical dosage forms and pharmaceutical technical procedure). Furthermore, I control performing analytical tests by technicians and take part in proficiency testing study organized by EDQM (European Directorate for Quality of Medicines).The member of group for implementation of ISO 17025 standard, as well as group for maintenance ISO 9001 and ISO 14001 standards. The assessment certificates of conformity (analysis) for imported batches – manufacturers outside of Serbia.

I was in charge of the quality control of medicines for human use (e.g. performing tests concerning identification, assay, impurities of pharmaceutical dosage forms and pharmaceutical technical procedure).

The analytical quality control of pharmaceutical dosage forms, active pharmaceutical ingredients (APIs) in chemical laboratory.I perform the development and validation of analytical methods.

Phd (Doctor Of Medical Sciences – Pharmacy), Pharmacy, Quality Control Of Medicines, Legislative Of Medicines

Activities and Societies: Published 4 papers in international journals (Chromatographia, J. Chromatogr. Sci.). Attended a lot of seminars.

Master Of Pharmacy, Pharmaceutical Technology, Pharmacology, Analytics Of Medicines

Activities and Societies: Attended short course at the Institute of Analytical Chemistry, University of Vienna. Attended a lot of seminars.