Your Expert Trainer
He has close to 40 years’ experience in the pharmaceutical industry. Pharmacist by education, He is one of the most well-known ‘Pharmacovigilance Professionals’ in Asia Pacific. He has rich hands o..
The Must Attend Pharmacovigilance Training Course in 2020!
Rising demand for drugs has significantly heightened the need for the development of novel therapeutics via extensive clinical trials, which in terms means companies involved in R&D and these extensive clinical drugs need to ensure they put in place robust Pharmacovigilance & Risk Management Plans & Programs to ensure they have efficient, strategically focused PV capability in order to be less reactionary, resource-intensive,and transaction focused, and become instead a more proactive agent for patient & drug safety.
Equip Global’s highly rated 3-day Pharmacovigilance Planning & Risk Management Training Course aims to critically explore existing and developing strategies to plan and optimise risk management activities for known and potential risks of a newly approved product. Regulatory aspects, Pharmacovigilance risk management plans, Risk evaluation and Mitigation Strategy, Periodic Safety Update Report (PSURs) and Periodic Benefit Risk Evaluation Report (PBRERs) will be the central theme. Group interactive sessions will analyse recent 'real-world' challenges faced by marketing authorisation holders and regulators
What Past Attendee Said?
"It was a great course to attend and was very insightful. Highly rate it for anyone in the industry." - Celgene
"Excellnt discussions and case studies. Very indepth and practical."- Roche
"I rate this course full score. It's a great coures and I highly recommend it if you are involved in pharmacovigilance OR drug safety." - Celltrion
Key Learning Objectives
- Appraise the founding principles of pharmacovigilance and landmark cases effecting change to recent drug safety issue
- Remain current with global regulatory changes to ensure compliance with new pharmacovigilance, risk management, and adverse event reporting initiatives
- Create a synchronized regulatory strategy that will ensure safety compliance in pharmacovigilance with FDA and EMA regulators
- Demonstrate good pharmacovigilance practice and locate key sources of information and documentation
- Utilize risk management tools such as Period Safety Update Reports (PSUR) and Risk Evaluation & Mitigations Strategy (REMS) to effectively evaluate internal risk
- Outline how to effectively prepare Periodic Safety Update Report (PSURs) and Periodic Benefit Risk Evaluation Report (PBRERs) to meet the regulatory requirements
- Undertake a risk benefit analysis of a newly marketed medicinal product, make and justify appropriate recommendations for communicating the updated information
Like more information?
Email us today at email@example.com! Group Discounted Rates are available too!