On November 22, 2017, EMA went live with a new and improved EudraVigilance database which was accompanied by updates to GVP Module VI (ICSR and Safety Reporting) and Module IX (Safety Signal Management). While the attempt to harmonize and standardize safety processes is welcomed, some functionality is not working as expected and there have been some unintended consequences of the changes which have led to an increased workload for many MAHs.
EMA has provided updates and fixes to help resolve the issues and a major upgrade is scheduled in February. Around the same time, the EudraVigilance Data Analysis System (EVDAS) pilot will be complete and fully implemented, so this is a good time to examine all aspects of this new update.
Continuing Education Credits are not available for this event.
Getting a product approved by the European Medicines Agency (EMA) can be daunting, especially for companies that have little experience with this unique and complex process. Within the EMA, the Committee for Medicinal Products for Human Use (CHMP) conducts a scientific data review and recommends whether or not the drug or biologic should receive marketing authorization. This presentation will walk you through how to prepare for, and manage CHMP meetings to achieve a positive recommendation for your product.
The regulatory and pharmacovigilance landscape is evolving substantially with the changing expectations from regulatory authorities. With the increasing number of drugs in the drug development pipeline and a parallel increase in the number of drugs being approved by major regulatory authorities globally, the costs continue to escalate. The pharma model for how clinical and safety data are acquired and managed throughout the lifecycle of a medicinal product needs to evolve and explore ways to decrease costs, increase efficiency, and achieve end-to-end (E-2-E) productivity. Drug development and pharmacovigilance have traditionally been predominantly human activities, recruiting large numbers of highly-trained and capable staff. Many hours of qualified staff are taken up performing routine and manual activities. Automation, however, has the potential to transform the current drug development and pharmacovigilance processes. With the incorporation of advanced automated technologies, several manual repetitive tasks can be automated. Therefore, highly-trained staff can focus on higher value work, consequently replacing, in some areas, roles that are entirely transactional.This webinar will:
Please join us for our seventh Professional Development Webinar, on May 3rd, from 12PM EST to 1PM EST, featuring Minnie Baylor-Henry, JD, RPh, President of B-Henry & Associates, a regulatory life sciences consulting firm.
She will be sharing some of her career experience as well as advice for moving forward in the field. After her introduction and talk webinar guests will be welcome to ask Minnie questions and advice. Her short biography has been included below. We hope to see you at the meeting!You can click the link below to register for the webinar (you will not be able to participate in the call unless you register). It is free to join and we would love to have you there!Professional Development Webinar with Minnie Baylor-Henry, JD, RPh, President, B-Henry & Associates
MINNIE V. BAYLOR-HENRY is the President of B-Henry & Associates, a regulatory life sciences consulting firm. In addition, she is the Executive Partner and Medical Devices Practice Leader for YourEncore, a leading provider of life sciences expertise. Prior to assuming her current roles, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson's (J&J) Medical Devices & Diagnostics business (2011-2015). Before returning to J&J in January 2011, Ms. Baylor-Henry was a National Director for Regulatory & Capital Markets Consulting at Deloitte & Touche. From 1999-2008, she worked in many executive leadership roles at J&J in the Pharmaceutical and Consumer businesses. Prior to joining J&J, Ms. Baylor-Henry worked for the US Food & Drug Administration (FDA). Ms. Baylor-Henry previously served as the Board Chair for the Food and Drug Law Institute (FDLI), as well as the President and Chair of the Board for the Drug Information Association (DIA). Currently, Ms. Baylor-Henry serves on the Board of Directors for Howard University, Dress for Success Boston, The Partnership, and the American Society of Health-System Pharmacists Foundation, as well as the Board of Visitors for Howard University's College of Pharmacy. Ms. Baylor-Henry received her Pharmacy degree from Howard University's College of Pharmacy and her law degree from Catholic University's Columbus School of Law.
Calling all students and emerging professionals for publication opportunities!
DIA is looking for student- and emerging professional-authored submissions to the Career Column in our monthly online publication, Global Forum. This is your opportunity to share your career advice, information on an interesting topics, or publish your own thought pieces!
Articles must be a maximum of 500 words and should be submitted to firstname.lastname@example.org.
Below is a list of potential topic ideas though we are more than open to any topics that you propose! We are even willing to help and work with you on shaping your piece. This is your chance to get published and shine!
Topic Ideas Include:
If you have any questions or ideas please feel free to email us at email@example.com.
RSVP for the Complimentary Student and Emerging Professional Forum at the DIA 2018 Global Annual Meeting!
RSVP to save your spot!
With the increase in size and complexity of the data associated with clinical studies, in particular oncology studies, using data standards, visualization standards, and sophisticated algorithms are necessary to provide medical writers, clinical data scientists, and medical officers with the information needed to perform their tasks in an efficient manner. Utilizing interactive summary graphics to drill down on populations of interest allows clinicians to focus on patients with the greatest efficacy response or safety issues. Upon finding these subjects of interest, medical writers and medical officers can explore their details by generating Adverse Event Narratives or Patient Profiles to understand their impact on the overall results of the study.
Brenda Crowe, William Wang, and Steve Wilson
Life is full of intended or unintended causes and effects. What started as an effort to get the estimators right with missing data in randomized controlled trials turned into an ICH guidance on getting the estimand right (ICH E9 R1 step 2). That inspired our highly popular DIA webinar series on "Getting the Questions Right (GTQR)".
In this final episode of our 2018 GTQR series, we are delighted to have three experts to summarize the public comments on the ICH E9 R1 (draft) and to look into the future on where the pursuit of GTQR may take us to the future. Come on board, fasten your seat belts, and enjoy the discussion!
Featured presentations and discussants
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Past webinars include:
Date: December 13, 2018 (Thursday) from 11:30 am – 1:00 pm US EST