Cost of education:
250 Euro + 200 Euro for each next participant
Target audience: authorized persons / their deputies responsible for pharmacovigilance at the global level and local offices, pharmacovigilance specialists, quality assurance specialists of the pharmacovigilance system, as well as specialists from outsourcing companies, internal audit specialists. Also, this webinar will be useful for clinical trial managers, clinical trial documentation development specialists, pharmacovigilance documentation development specialists, enterprise quality system management specialists, pharmacovigilance directors, and medical directors.
Questions will be considered
• Regulatory framework for the development of a quality system for the pharmacovigilance system at the global and local levels (Ukraine, EAEU countries, Moldova, Uzbekistan, Azerbaijan, EU countries).
• Standard operating procedures: Standard operating procedure requirements, SOP structure; Process Description Algorithm.
• How to correctly divide the process into separate procedures.
• Definition of the list of required SOPs, global and local level of the pharmacovigilance system, practical examples.
• Determination of the list of required standard operating procedures for distributors.
• Critical processes of the pharmacovigilance system.
• Ensuring the continuity of pharmacovigilance system processes (standard operating procedures).
• Specific processes of the quality system of the pharmacovigilance system.
• Ensuring the quality system of the pharmacovigilance system in the processes.
• Work instructions as an element of the quality system documentation of the pharmacovigilance system (local and global). Practical examples.
• Interrelation of standard operating procedures at the global and local level. Practical examples.
• Reflection of the processes of interaction of the pharmacovigilance system with other departments of the applicant in standard operating procedures (at the global and local levels).
• Reflection of standard operating procedures in the master file of the applicant's pharmacovigilance system.
• Major challenges and mistakes in the development of standard operating procedures.