Pharmacovigilance in the context multidisciplinary and transdisciplinary approach in the clinical and regulatory field. Challenges and opportunities


Online training
November 23
Trainer: Galyna Cordero

Galyna Cordero
MD QPPV of Farmak JSC since 2011, Head of pharmacovigilance department since 2014. Experience in building, maintaining, implementing and ensuring the proper functioning of the pharmacovigilance system, 9 years of experience as a clinical expert of Farmak JSC, conducting audits of the pharmacovigilance system for international partners, in risk management and signal management in pharmacovigilance, generation of pharmacovigilance documents with SOPs, master files of the quality system in pharmacovigilance, as well as RMP, PSURs, ASOs for Ukraine, CIS countries and well-regulated markets in Europe and Asian countries. Direct participation in international clinical trials and bioequivalence studies in terms of pharmacovigilance. Higher medical education, additional training in pharmacovigilance and GCP in England, the Netherlands, Germany, Austria.
Date: November 23, 2023
Format: 2 hours
Start of the training: 10:00 (GMT +2)


Preamble


Drug safety and pharmacovigilance have emerged as a dynamic clinical and scientific discipline to provide adequate information and ensure health safety by the joint interaction of health care professionals and patients in choosing appropriate treatment methods and drugs.

Pharmacovigilance focuses on drug actions, adverse reactions, and overall drug quality and monitors its effect on the health care system, thus protecting the patient population.

We will discuss the updates, opportunities, and challenges alongside fresh problem-solving strategies of pharmacovigilance and drug safety that matter most to pharmacovigilance and drug safety professionals of MAH and healthcare professionals and how it contributes to public health.


Attendees include Chief Data Officer, VPs, GMs, Directors, Heads and Managers of

  • Pharmacovigilance
  • Safety & Risk management
  • Drug safety
  • PV Compliance
  • Safety Surveillance
  • Medical Affairs
  • Regulatory Affairs
  • Inspection and Audit
  • Pharmacoepidemiology
  • Post-market studies
  • Medical product safety assessment
  • Drug Research & Development
  • Clinical Pharmacology
  • Medical information
  • Contract outsourcing service providers
  • Health outcomes
  • Sales and Marketing
  • Health care professional

Program

1. Significance of Pharmacovigilance. Challenges in Pharmacovigilance.

2. Pharmacovigilance specialist: the way of the warrior. Challenges and perspective.

3. The need of pharmacovigilance.

4. Regulatory Compliance and Accountability.

5. Pharmacovigilance Approaches & Impact.

6. Features of a Responsive Network.

7. Multi‑Directionality, Problem Centeredness, Trans‑Disciplinarity approaches.

8. Creating a Responsive Network.

9. Recommendations to Increase the Impact of Pharmacovigilance : strengthening the bridge between healthcare professionals and MAH.

10. Medication Safety/Drug safety Education Program as a tool for risk minimization measures and prevention adverse reaction.

11. Continuous Improvement in Patient-Centric Care.


Registration
FREE PARTICIPATION

Organizers
"Standards Technologies Development" STD Ltd is a training company with extensive experience in the training market for employees of pharmaceutical companies, as well as employees of food and chemical industries, laboratories.
PharmEducation. PRO is a portal that collects the best and most relevant trainings and courses for farm workers. More than 200 specialists from Ukraine, Kazakhstan, Latvia, Estonia, Armenia, Georgia, Uzbekistan, Azerbaijan study on the portal every month.