This Webinar on Pharmacovigilance Procedure in Ukraine covers all important topics in concise 90-minute presentations that ALL of your employees will be able to learn and implement in creating your Pharmacovigilance system as per Ukraine Regulatory requirement. The Webinar will be based on the recent amendments on Good Pharmacovigilance Practices Guidelines by Ministry of Health of Ukraine dated April 5, 2018. On the 10th of February 2016, The Ministry of Health of Ukraine published on its website the draft decree "On Amendments to Some Decrees of the Ministry of Health of Ukraine" (hereinafter - the draft decree), which proposes a number of changes in the relevant Ministry regulations. The most important among the suggested amendments is the one concerning the Procedure of monitoring of adverse reactions to medicinal products permitted for medical use as approved by decree 898 of the Ministry of Health of Ukraine, dating December 27, 2006 (hereinafter - the current procedure), in the new edition, changing its name to "The Procedure for the Conduct of Pharmacovigilance" (hereinafter - the new procedure).
At the conclusion of this tutorial, participants will be able to:
- How to create and manage a Quality system in Pharmacovigilance
- How to create and maintain your Pharmacovigilance system Master File.
- How to make your system (with SOPs, WIs, Manuals etc.) for Audits and Inspections
- How to prepare and submit Risk Management Plans (RMP)
- How to create your Pharmacovigilance system for collection, processing and reporting of ICSRs
- How to prepare and submit the PSURs
- Post - registration Safety Study
- Signal Management
- Additional monitoring
- The process of communication on security issues
- Measures to minimize risk: selection tools and performance metrics
Academy of Clinical Intelligence
Sunil has been in the Clinical Research Industry for over 10 years. He held the position of Director of Trainings for a leading Contract Research Organization, HAROM Solutions. His company facilitates the business sector by providing Pharmacovigilance services to Pharmaceutical companies and technical trainings to Medicine, Dental, and Pharmacy, Life Science professionals internationally in the fields of Pharmacovigilance, Clinical Research, and Medical Writing etc. He has been involved in trainings throughout his career particularly in the areas of Pharmacovigilance including ARGUS Safety, Clinical Research and Medical Writing. With over 10 years of experience in the pharmaceutical industry and clinical research organization, Sunil offers his clients the assurance that their drug safety training programs are being conducted by a seasoned pharmacovigilance executive with experience in developing, implementing and leading safety trainings in lower cost markets.
Sunil was formerly Manager, Trainings & Operations of Clinical Research and Pharmacovigilance, where he successfully developed and led more than 8 therapeutic area teams and support training and operations functions for the management of Clinical Data and Adverse Event reporting for human health, including all phases of a product life cycle (drugs, vaccines and devices). Sunil is a client certified trainer with expertise in techno-functional training on Oracle Argus Safety 7.0 including Argus activities, User management, Case processing including duplicate check, case book-in, follow up, coding, medical review, reports generating (Expedited, Aggregated, PSUR) and dashboard reports. He ahs proficiency in WHO-DD and MedDRA Dictionary and knowledgeable in various regulatory guidelines like ICH guidelines, Good Clinical Practices, Good Documentation Practices and Volume 9A etc.
If you are involved in any aspect of Pharmacovigilance or planning to start your Pharmacovigilance System in Ukraine and looking forward to strengthen your Pharmacovigilance knowledge as per regulatory standards in Ukraine, this webinar will help you to increase your knowledge base regarding the techniques and regulatory processes involved in creation and maintenance of Pharmacovigilance System in Ukraine.
This will be a perfect learning opportunity in all areas of drug safety, Pharmacovigilance, regulatory and quality compliance and will be a great addition to your knowledge in Pharmacovigilance.
All professionals are involved in:
- Pharmacovigilance (including QPPV)
- Clinical Research
- Risk Management
- Drug Safety Assessment Department
- Safety Data Analysis
- Information Technology
- Regulatory Affairs
- Pharmacovigilance consultancy
- Quality and Compliance