The region's biggest digital marketing event and peer meet & greet. Latest and future digital marketing innovations and trends from cross industry experts. Digital marketing impact on business performance. Influencing consumer behavior through digital marketing. #Outreach18
Prepare for the new EudraVigilance obligations starting this November
Applicable to both marketing authorization holders and national competent authorities, new obligations regarding signal management and ADR reporting will come into force on November 22, 2017. This should end the transition period of the pharmacovigilance legislation from July 2012.
New obligations concern the following four areas:
1. Signal management
Processes within signal management will be updated and described in detail in the upcoming revision of Guideline on good pharmacovigilance practices (GVP) Module IX – Signal Management (expected to be published at the end of this year).
2. ADR reports
For marketing authorization holders, there are a few important changes in electronic reporting requirements expected:
• Marketing authorization holders will be sending reports of suspected adverse drug reactions (with submissions under Regulation (EC) No. 726/2004 and/or Directive 2001/83/EC) directly to EudraVigilance. Afterwards, they will be re-sent to the relevant Member States.
• Instead of receiving them, marketing authorization holders will have to download ADR reports directly from EudraVigilance.
• Non-serious ADR reports from the EEA should be submitted to EudraVigilance within 90 days.
• Coming into force on 22 November 2017, the revised Guideline on good pharmacovigilance practices Module VI - Management and reporting of adverse reactions to medicinal products should be adhered to.
3. ICH E2B(R3) format
The current ICH E2B(R2) format will be replaced with the new ICH E2B(R3) format, influencing the content of ADRs. Used for the electronic exchange of ADRs, it will serve to improve the data quality.
4. Art 57 database
In order to comply with the new EudraVigilance obligations, all marketing authorization holders have to make sure that their data in the Art 57 database is always complete and up to date.
Prepare for your new obligations with Shelley Gandhi, leading expert with over 20 years of experience in pharmacovigilance, at the upcoming Signal Detection Throughout Products Life-Cycle – Pre to Post Authorization training (28 – 29 September 2017, Amsterdam, Netherlands).
Interested in this topic?
Regulation & Safety in Cosmetics
Over the past five years, the cosmetic industry has met with several legislative changes. Within the new legislative package, including the new REACH and CLP, it is important to find a comfortable routine that will minimize costs while staying effective and compliant with all regulations.
Sales & Marketing Effectiveness in Chemicals Forum
The Sales & Marketing Effectiveness in Chemicals Forum will bring together industry leaders as well as experts responsible and deeply involved in sales and marketing strategies.
Corporate Compliance & Transparency in the Pharmaceutical Industry
This two-day conference will serve as a platform for an open and dynamic dialogue with HCPs and patients to achieve common goals. Learn how to embed compliance in the business and develop one simple system for managing compliance & transparency in a complex and regulated environment.
Sales and Marketing in Insurance
Currently, insurers must compete not only among themselves, but also with insurtech startups and disruptors. This event focuses on the latest trends in channel management, digitization, customer-centric strategies, digital customer journeys as well as product innovation.
Smart Workspace Design Summit 2016
Have a look on the infographic about the Smart Workspace Design Summit 2016.
Post Show Report 3rd Annual Oil & Gas Forum
Post Show Report from 3rd Annual HR Oil & Gas Forum
How important is the color of a car?
Have you ever thought about how important the color of a car is for insurers and insurants?