RAPS & MakroCare is organizing a Seminar on Regulatory Intelligence at Ardmore, PA, USA.The Reg Intelprovides updated regulatory data from multiple sources for IRB/clinical submissions, market authorization, safety reporting, manufacturing, LCM and other details. The speaker of the Seminar is Alexis Miller, Sr. Director Regulatory Policy & Intelligence and Regulatory Affairs, Eisai, Inc.
At the RAPS Philadelphia chapter, MakroCare is sponsoring a Seminar on “Regulatory Intelligence – It’s Not Just a Buzz Word Anymore”
What will you take with you:
– How the Global Regulatory landscape is changing constantly
– What is RI, how important it is to keep abreast of worldwide regulatory information in today’s world
– What impact RI has on shaping Regulatory Policy
– Where one can find RI and how reliable is that info
– How to leverage RI tools
Alexis Reisin Miller is Senior Director, Regulatory Policy and Intelligence at Eisai Inc. Alexis is a member of Eisai’s Global Regulatory Affairs unit, and works with the Public Policy, Development, Commercial, Government Affairs, Legal, and other departments on a variety of regulatory and policy matters ranging from premarket(product creation and development) through commercialization. Through the commenting process, presenting and attending conferences, participating in working groups, and other outreach activities (e.g., working with industry organizations, FDA, and external colleagues), Alexis contributes to regulatory policy dialogue as it evolves, with the ultimate goal of helping to shape the regulatory environment.
Agenda of the Evening:
5:30 -6:00 pm – Welcome and Networking, Speaker Introduction
6:00- 7:00 pm – Presentation and Questions
7:00 to 8:30 pm – Open table discussions, Networking
Date/Time: 10 December 2015 I 5:30–8:30 pm EST
Venue: Primavera Pizza Kitchen, Ardmore, PA
Speaker: Alexis Miller
Sr. Director, Global Regulatory Policy & Intelligence
Global Regulatory Affairs, Eisai, Inc.
Click on the URL to Register: https://www.raps.org/EventDetails.aspx?ProductId=76806133
MakroCare’s VISTAAR, global regulatory intelligence specially is designed for Regulatory (Strategy, Policy, Operations, Submissions) teams in BioPharma and Medical device companies. It provides updated regulatory data from multiple sources for IRB/clinical submissions, market authorization, safety reporting, manufacturing, LCM and other details.
VISTAAR will keep life science professionals up to date with the constantly changing/evolving regulatory environment with an easy access to continuously updated accurate drug regulatory information.
In addition, custom research projects on regulatory intelligence are also handled by VISTAAR’s experienced team.