The Rundown: ExL’s Blog
Viewing 1 to 10 of 136 records.
Prioritizing Clinical Quality: J&J, Biogen and Alexion Drive Top-Down Approaches
Tuesday August 14th, 2018
Learn how leading pharma, biotech, and device companies are driving a quality culture at the 9th Clinical Quality Oversight Forum, taking place October 10-12 in Philadelphia. Join more than 175 clinical quality, compliance, and operations professionals to strategize on how to effectively oversee both vendors and sites, and learn best practices for achieving ICH E6 R2 compliance.
Discounted Pricing Is About to Expire for the Biggest PRC Conference Yet!
Monday August 13th, 2018
This year’s 6th Promotional Review Committee Compliance & Best Practices conference (Sept. 24–26, Morristown, NJ) is our biggest yet! For the first time, we are offering a three-day event and FDA participation! Don’t miss out on over seven hours of networking opportunities with our expert speaking faculty, discussing such topics as:
Formulate a Social Media Comment-Moderating Policy When Clear Guidance Signals Are Lacking
Stephanie Jameison, Director, Global Regulatory Affairs, Promotion Compliance, OTSUKA
Sabrina Mays-Diagne, Senior Corporate Attorney, OPDC Legal Affairs, OTSUKA
Heather Ramirez, Senior Corporate Counsel, NOVO NORDISK
Resolve Unanswered Questions About Using Off-Label Information
Cecilia Bakker, Assistant General Counsel, PFIZER
View the Detailed Agenda for the 14th Pharma Meeting Pros Summit — Nov 13–14 in New Jersey
Thursday August 9th, 2018
We are so excited to release the detailed agenda for the 14th Pharmaceutical Meeting Professionals Summit, taking place November 13–14 at the Hyatt Regency New Brunswick in New Jersey. Remember to register early for maximum savings. Click here and use Priority Code C1012EM5.
Alice Woychik, Head, Meetings, Congresses, Events and Operational Controls, NOVARTIS BUSINESS SERVICES
EXPERT PANEL: WHAT KEEPS YOU UP AT NIGHT?
Identifying the Barriers to Productivity and Process Optimization and Discussing Strategies to Overcome Them
Rick Rinderle, CME, CMP, HMCC, M.Sc., Associate Director, Meeting…
AGENDA AVAILABLE — AI Innovations for Life Science Summit West
Wednesday August 8th, 2018
Business leaders in the life science sector understand the value of learning about trendy machine learning algorithms and artificial intelligence platforms from experts who have applied them to primary activities in their enterprise. This is why ExL is excited to release the agenda for the AI Innovations for Life Science Summit West, taking place November 6–7 in San Francisco.
From early R&D to commercialization, our speaking faculty will dive into examples of…
Final Week for MASS West 2018 Discounted Prices
Tuesday August 7th, 2018
This is the last week to receive discounted pricing for MASS West 2018, taking place September 24–26 in San Diego, and I want to make sure you reserve your seat in time. Take advantage of our Early Bird pricing by registering by Friday, August 10, and save $200 off the standard rate!
View the brochure to see the full breadth of stakeholder voices and perspectives represented at MASS West 2018.
This is the leading industry event that provides practical insights and actionable solutions for addressing the day-to-day challenges faced…
Get Ready for the Life Science Administrative Excellence Forum
Friday July 27th, 2018
As pharmaceutical and biotechnology companies expand to meet global medical needs, the role of the administrative professional has never been more indispensable than in today’s drug and device development sector.
This is why ExL Events is excited to release the agenda, jam-packed with administrative thought leaders, for the Life Science Administrative Excellence Forum, taking place November 28–29 in Florham Park, NJ. This inaugural event will be a platform for administrative professionals to share best practices for internal and external communications, among other essential skills, which enable admins to rise through the ranks with their leadership.
FDA Withdraws Biosimilar Draft Guidance After Public Outcry
Friday July 27th, 2018
In a monumental move, the FDA has withdrawn the “Statistical Approaches to Evaluate Analytical Similarity” draft guidance. This decision comes after public comments and even a citizen petition forced FDA Commissioner Dr. Scott Gottlieb and co. to about-face on this guidance.
“As the cost to develop a single biosimilar product can reach hundreds of millions of dollars, it’s important that we advance policies that help make the development of biosimilar products more efficient, and patient and provider acceptance more certain,” Gottlieb said, according to Forbes.
Dr. Sarfaraz Niazi, Ph.D., Adjunct Professor, Department of Biopharmaceutical Sciences at…
Featured FDA Advisory Committees Strategy Summit Sessions and Speakers
Thursday July 26th, 2018
The FDA Advisory Committees Strategy Summit’s brochure is now available! Mark your calendar for November 5–6 in Virginia to learn how to enhance the likelihood of a successful panel meeting with the FDA!
Use Discount Code 797918BLOG.
Identify Your Audience
Aden Asefa, MPH, Regulatory Health Project Manager, U.S. Food and Drug Administration
Examine the FDA Advisory Committee Selection Process to Understand the Backgrounds of Advisory Committee Members
Elijah Wreh, Regulatory Affairs Manager, INVACARE CORPORATION; Industry Representative, FDA ADVISORY COMMITTEE NEUROLOGICAL DEVICES PANEL
Navigate Regulatory Updates and Standards
Jack Weet, Vice President, Regulatory Affairs and Quality Assurance, COLLEGIUM PHARMACEUTICALS,…
Maximize Inspection Readiness and Trial Success
Wednesday July 25th, 2018
Are you and your company looking to adopt and understand all requirements to have a better chance of warding off inspections and being more successful in the outcome of your trials? With inspections being a crucial part of clinical trials, we have gathered at the 7th Clinical Trials Inspection Readiness Summit, taking place August 13–14 in Philadelphia.
Join us and network with industry professionals exploring how to maximize inspection readiness and trial success through better documentation and operational standards. You will learn from interactive sessions, case studies and panel discussions that will give you the tools and strategies needed to improve your…
Europe TMF Executive Summary Available Now!
Thursday July 12th, 2018
We invite you to download the Executive Summary from last year’s 6th European Trial Master File Summit.
More than 25 esteemed TMF professionals from leading pharmaceutical and medical device companies discussed topics such as:
Quality control processes and budget constraints managements
Quality management dimensions for TMF
Due diligence on vendor eTMFs
eTMF metrics and data quality
Safety requirements of TMF plans and strategies
… and more!
DOWNLOAD THE SUMMARY
At this year’s 7th European Trial Master File Summit, taking place 15–17 October 2018 in London, participants will have the opportunity to connect directly with an MHRA inspector and…
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