2 Usefull Webinars on Pharmacovigilance, Stability Studies and Estimating Shelf Life
Product ID : PHARMA-FDA-0001
Level : Intermediate
Pragmatic Approach to Pharmacovigilance/Drug Safety System Update Against the Latest New Requirements
Presented by Marco Sardella
In the last year/recent months, there have been a lot of changes in the pharmacovigilance requirements especially impacting the reporting to EudraVigilance, the Signal Detection Management (e.g. inclusion of EudraVigilance Data Analysis System as part of the Signal Detection Management, etc.), and the Risk Management activities. The course is aimed at providing some practical examples of the application of the new requirements to PV Systems.
The recent new published modules of the Good Pharmacovigilance Practice (GVP) and in particular the new GVP module VI "Collection, management, and submission of reports of suspected adverse reactions to medicinal products", the new GVP module V "Risk Management Systems" and GVP module IX "Signal Management" required for an update to Safety Databases/electronic interchange systems, processes/working instructions, contracts with Third Parties affected from such legislative changes, etc. The review and update of Pharmacovigilance Systems as a result of the new requirements must take into account the type of medicinal products covered by the systems. Any update required to meet new local requirements from a specific territory will have to be performed in a way that does not generate conflicts with the functionalities of the system in place to meet the requirements of other territories.Stability Studies and Estimating Shelf Life with Regression Models
Presented by Steven Wachs
Manufacturers of foods, drugs, consumer goods, and other products must determine the shelf life of their products so that customers know when the product can be expected to perform as intended. Many approaches are available to quantify the "shelf life" and the method(s) chosen often depends on the testing time available. This webinar discusses the steps to set-up a stability study and analyzes the results to estimate the product's shelf life. The use of regression models to model the relationship between the response variable(s) and time is presented. Models useful for describing non-linear degradation over time are also presented. Additionally, methods for handling non-normal response data are also discussed. Finally, the use of accelerating variables to shorten the study time and the models required are introduced. The webinar includes several examples to illustrate the methods discussed.
The webinar will provide useful methods and techniques for conducting a stability study and analyzing the resulting data for the purpose of estimating shelf life. Participants should be able to immediately apply the methods presented. Also, the interpretation and communication of results will be stressed.
Marco Sardella, Chief Pharmacovigilance Officer EU-QPPV-ADRIENNE Pharma & Biotech Dr. Marco Sardella is a PV Person with significant experience in setting up pharmacovigilance and risk management systems worldwide (experience with EMA, USA, Canada, Switzerland, Russian Federation, Asia, Middle East). Former European QPPV of Gentium S.P.A/Jazz Pharma. Today, overall Responsible for Global Safety and Pharmacovigilance for the Group ADRIENNE Pharma and Biotech in the position of Chief Pharmacovigilance Officer & European QPPV. Experience with the development of CTD safety modules for hemato-oncological products [successful approval in the US, Canada, (New Drug Applications) and EMA (Marketing Authorization Applications)]. Responsible for Safety in international pre-approval and post-approval safety studies.
Steven Wachs has 25 years of wide-ranging industry experience in both technical and management positions. Steve has worked as a statistician at Ford Motor Company where he has extensive experience in the development of statistical models, reliability analysis, designed experimentation, and statistical process control. Steve is currently a Principal Statistician at Integral Concepts, Inc. where he assists manufacturers in the application of statistical methods to reduce variation and improve quality and productivity. He also possesses expertise in the application of reliability methods to achieve robust and reliable products as well as to estimate and reduce warranty. In addition to providing consulting services, Steve regularly conducts workshops in industrial statistical methods for companies worldwide.
The 2 webinars in this bundle will quickly review and update the Pharmacovigilance Systems. It will also explain the recent new published modules of the Good Pharmacovigilance Practice and the new GVP module VI "Collection, management, and submission of reports of suspected adverse reactions to medicinal products", the new GVP module V "Risk Management Systems" and GVP module IX "Signal Management" required for the update to Safety Databases/electronic interchange systems, processes/working instructions, contracts with Third Parties affected from such legislative changes. It will also discuss the steps to set-up a stability study and analyzes the results to estimate the product's shelf life. It will provide useful methods and techniques for conducting a stability study and analyzing the resulting data for the purpose of estimating shelf life.
The webinar format is 1-1.5 hours of audio-visual presentation, including a brief Q&A session.
This webinar bundle includes below 2 recorded webinars: