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Encore of 10th Annual

Pharmaceutical Regulatory Operations & Submissions Conference

December 1-2, 2021 | Virtual Event

Streamline compliant regulatory dossier submissions by navigating global guidances, technology & resource management
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Program Overview

Engage in discussions with the FDA and learn how to fast-track your products to market with other industry executives and regulatory leaders at this pharmaceutical conference in October. Regulatory and submission publishing operations experts will share their experiences and knowledge on completing compliant regulatory dossiers to secure timely product approvals. You will also navigate the creation of submission dossiers and efficiencies in streamlining the dossier development process, including technology and AI integration, through resource management considerations.

Group discussions will cover global regulatory nuances, strategies surrounding ad/promo submissions and lessons learned from responding to submission rejections.

Main topics include:

  • FDA review of ECTD guidance & specification updates
  • Panel discussion on time-saving strategies to meet accelerated regulatory
  • Submission timelines
  • Superior performance through automation of workflow processes
  • Formatting promotional materials for electronic submission integration

Featured speakers include:

  • Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
  • Meghan Mendoza, MBA, RAC, Head, Global Regulatory Operations, Global Regulatory Affairs, AMGEN
  • David Ross, , Global Regulatory Operations Strategy & Change Mgmt., Clinical/Regulatory, Liaison, ASTRAZENECA
  • Sharon Lobo, Oncology Program Director, Regulatory Planning & Execution, MERCK

This program offers three half-day modules to maximize retention and engagement. Q1 Production’s premier event platform offers a refreshing and unparalleled virtual experience. Thoughtfully designed, customizable, networking features foster a sense of collaboration, discussion, allowing attendees to make direct connections.

Download the full agenda or call one of our representatives to learn what makes Q1 Productions events so different from other industry events. Learn more today!

Countown to Encore of 10th Annual Pharmaceutical Regulatory Operations & Submissions Conference:

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Experience the Quality First Difference.

Learn from Industry Leaders

An exclusive experience with professional thought leaders provides you with direct insight into current solutions.

Keep up with Industry Trends

Learn through dynamic panel discussions, case studies and real world evidence on current topics directly related to your industry.

Exchange Ideas & Network

We provide a platform for your team to ask questions with experienced industry experts. The key to building your knowledge and seeing things from another perspective.

Find Solutions that Work for You

Insight and interaction are at the ready for you and your team. Collaborate with your peers, utilizing their insight and experience to accommodate your common challenges.

“Very useful to get your mind off of what only your company is doing and into other people’s experiences. This was my first Reg Ops/Subs conference and I want to attend the next one.”

Megan Murphy, Senior Regulatory Operations Specialist, Flexion Therapeutics

Distinguished Presenters Include:

Vishu Manegari
Senior Director, Regulatory Operations
GILEAD SCIENCES

Vada A. Perkins
Exec. Director, Reg Policy & Intelligence, Head, Regulatory Intelligence
BAYER PHARMACEUTICALS

David S. Ross
Director, RIM, Capability Global Regulatory Operations
ASTRAZENECA

The Q1 Productions Virtual Event Experience

“It exceeded my expectations! In my opinion, the true value of Q1 conferences is that they are small and allow for open and fluid discussion. That’s a rarity and it sets you apart from others. Plus, having an RI specific conference is wonderful!”

Kimberly Belsky, Senior Director, Regulatory Intelligence, Mallinckrodt Pharmaceuticals

Attendees by Job Title

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Reach out to us with any questions.

Our team will respond promptly!

Rob Britt Photo
Rob Britt
Senior Event Manager
Q1 Productions
+1 (312) 224-8773
rbritt@q1productions.com

www.q1productions.com