Activities

Major qualifications
Monitoring and management of clinical trials; medical affairs (more than 10 years of experience)

• Phase II - IV clinical trials;
• Bioavailability/Bioequivalence trials;
• Project management;
• Logistics;
• Medical writing;
• Medical advisor;
• Pharmacovigilance;
• Legal expert on clinical trials in Bulgaria;
• Regulatory support on Bulgarian drug legislation regarding clinical trials.
• Regulatory policies and legislation rilated to clinical trials at the Bulgarian Drug Agency

Drug regulatory affairs - (more than 20 years of experience)

• Regulatory policies directed to marketing authorization procedures at the Bulgarian Drug Agency (DP and MRP and national procedures) and also
• Consultants services at EMEA level where the Bulgarian language (SmPC and PIL) is needed;
• Advises on local requirements for national applications as well as MRP, decentralized and centralized (NCES, Variations, renewals);
• Provide intelligence on legislative changes (ongoing and future) to local requirements;
• Prepare good quality translations where needed. In particular to translate packaging, artworks and SPCs and prepare local artworks.
• For centralized products to meet the EMEA translation timings.
• To submit and co-ordinate maintenance related to approved products as necessary (variations, renewals, PSURs).

Related to clinical trials affairs

Intellectual properties for pharmaceuticals in Bulgaria

Outcome research

Training activities:

In the field of clinical trials:

• Initial training on the role and responsibilities of the CRA, Study Site Staff and Sponsor plus the Local Regulations and International ICH Guidelines and Good Clinical Practice (GCP).
• "Hands on experience" in actual monitoring situations such as Investigator Selection, Contacts with Regulatory Authority and Ethics Committees, CRF Review, SDV, Drug Accountability and Adverse Event assessment.
• Additional training on different topics, key for the monitoring excellence:
  • The EU clinical trial Directive;
  • Adverse events - Understanding and Reporting Requirements;
  • Detecting Fraud and Misconduct in Clinical trials;
  • Improving Investigator Site Performance;
  • Developing of training courses according to client's needs;

In the field of Regulatory Affairs:

Training on:

• Pharmaceutical legislation in the EU (Directives and Regulations)
• Marketing authorization procedures;
• Pharmacovigilance;
• Pricing and reimbursement;