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The Rundown: ExL’s Blog

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Just Announced: 15th Public Relations & Communications Summit, July 22–23 in NJ

ExL is excited to announce that the 15th Public Relations & Communications Summit is taking place on July 22–23 at Novo Nordisk in Plainsboro, NJ. This event is the ONLY conference dedicated to providing life science communicators with industry updates and best practices for successful communications strategies during today’s complex healthcare environment.

Don’t miss out on the opportunity to network with your peers and other industry professionals.
This year attendees can expect to:

Understand the internal and external structures and roles within an organization
Network with all levels from junior, mid-level, and senior
Broaden views beyond the audience and hear…

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Chair Message: 5th Payer Partnership Forum

As the chairperson of the 5th Payer Partnership Forum, I invite you to join me in Boston on June 10–11, 2019, for this innovative and collaborative event. This year’s conference will arm attendees with vital information on the most important topics in managed care and pharmaceutical delivery that will foster partnerships with payers in a venue that will provide valuable networking opportunities with representatives from across the healthcare value chain. The 2019 Forum creates mutually beneficial partnerships through collaborative discussions centered on value-based engagements, specialty pharmacy, and patient adherence.

To view the full program, click here.

As chairperson, I am excited to…

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Brochure Available: European Pharmaceutical Meeting Professionals Summit

ExL Events proudly extends their well-known Pharma Meeting Pros Summit to Europe. Participate in a research-based, educational programme on meeting and event planning in the life science industries, offering an intimate and interactive setting, ideal for networking and learning.

Join your peers on 4–5 June in Barcelona.

Click here to register!

Samme Allen

CONFERENCE CHAIR
Samme Allen, MC-Facilitator-Moderator, SAMME ALLEN LTD

Download the brochure now!
Featured Session Topics
GLOBAL MEETING MANAGEMENT
Overcome Common Challenges to Global Meeting Optimisation and Best Practices for Success

TOP COMPLIANCE CHALLENGES
Evaluate the Top Compliance…

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The First OPDP Warning Letter of the Year Goes to…

…Sodium Acetate, or 11-C Acetate, an unapproved drug. OPDP wrote their first warning letter of the year to an investigational drug at the Phoenix Molecular Imaging Center. They’ve claimed that 11-C, which acts as a PET scan for detecting recurrent prostate cancer, is misbranded.

As there is a grey area for Phoenix answering various, everyday questions of “what is available,” “how do they compare,” and “what are the parameters for successful imaging,” the FDA claims that their webpage is promoting the investigational drug as safe and effective while still going under investigation.

You can read more on this particular case 

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Final Week to Save for the 6th Promotional Review Committee Compliance and Best Practices — Midwest Conference

The 6th Promotional Review Committee Compliance & Best Practices – Midwest, taking place May 15–17 in Chicago, is a one-of-a-kind event you can’t afford to miss!
Our 2019 conference will cover top strategies for:

Complexity-based tiering of PRC responsibilities
Managing documents access and accuracy in spite of regular turnover
Efficiently leading PRCs amidst high material volume
Maintaining team skills and readiness during mergers, acquisitions, and divestitures

…and MUCH MORE! Download the brochure for more details on what you can gain from attending during this three-day event of networking and education.
Reserve Your Seat Today!
Featured Speakers

Nneka Onwudiwe, Regulatory Reviewer, FDA
Bradley Coushman, Vice…

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Attendee’s Takeaways: 5th Clinical Trials Phase I & Phase IIA Summit

Applied Clinical Trials recently shared an attendee’s takeaways from ExL Events’ 5th Clinical Trials Phase I & Phase IIA Summit, which took place this past Autumn.

In this article, Moe Alsumidaie, MBA, MSF (Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member/contributor to Applied Clinical Trials) discusses the following three subjects and how ExL’s conference explored them:

Adaptive design in protocol writing

Designing safer early phase studies

Monitoring oversight in early phase trials

For a more complete look at these topics and to learn more about our Clinical Trials Phase I &…

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6th Promotional Review Committee and Compliance and Best Practices — Midwest Conference Brochure Available NOW

At the 6th Promotional Review Committee and Compliance and Best Practices — Midwest Conference on May 15–17 in Chicago, attendees will network with over 20 industry experts from Takeda, Alkermes, AbbVie, Genentech, GSK, and more. This is an educational environment with a full day dedicated to workshops and 15 sessions exploring ways to improve PRC teamwork and speed while maintaining expertise even with changes in team composition and regulatory expectations.
View The Brochure
Featured Sessions on Optimizing PRC Training and Teamwork:
Properly Sequence Input From Medical Reviewers
Alexander Shaw, Manager, Medical Information, Alkermes

Select and Implement CAPAS From Promotional Review
Nan…

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Brochure Released: AI Innovations for Life Science and Healthcare Summit East

The agenda for the AI Innovations for Life Science and Healthcare Summit East is now complete! Join our expert speaking faculty of over 30 life science, healthcare, and tech professionals on June 13–14, 2019, in Philadelphia, as we elevate clinical trial operations, healthcare outcomes, and supply chain implementation through AI.
DOWNLOAD THE BROCHURE
 
Featured Speakers

Prasanna Rao, Head, Artificial Intelligence and Data Science, PFIZER INC.

Leslie Cousens, Director, Translational Medicine, ASTRAZENECA

Brian Martin, Head of AI, ABBVIE

Christine Sawicki, R.Ph., MBA, LSSMB, Director, Specialty Clinical Innovation and Program Development, CVS HEALTH

Christopher Jordan, Chief Technology Officer, CLICK THERAPEUTICS

Maria Palombini, Director,…

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Join 110+ Clinical Quality and Operations Professionals in Philadelphia, March 18–20

There’s still time to register for next week’s 10th Proactive GCP Compliance Conference that is taking place on March 18–20 in Philadelphia. With a focus on ICH E6 R2 compliance, gain the foundation needed to determine your company’s level of compliance and where you should focus your efforts to achieve a confident state of inspection readiness.

Session topics include:

Risk Identification
Risk Control and Communication
Risk Review and Reporting
Monitoring Post R2 Essential Documentation
CRO Oversight
Root Cause Analysis and CAPA
Quality Culture…

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“Technology Optimized Content” — 6th PRC Panel Moderator Reflects on Conference

In a new article for www.pm360online.com titled “Technology Optimized Content,” Ilyssa Levins (President of the Center for Communication Compliance) reflected on her experience as an attendee of and panel moderator at ExL Events’ recent 6th Promotional Review Committee Compliance & Best Practices conference.

The article points out that content quality optimization is dependent upon the promotional material’s ability to obey the following guidelines:

Do not violate any well-established requirements that are not risk tolerance issues
Address FDA guidances which include many sub-requirements
Have no editorial and grammatical errors or typos

Levins also touches on topics like The Value of Technology, High-Tech…

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