8th Annual Pharmaceutical Regulatory Operations and Submissions Conference

June 11-12, 2019 | Philadelphia, PA
Renaissance Philadelphia Airport Hotel
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“I thought the conference was excellent!  Having a conference tailored to one discipline made each panel and contact relevant.”

Director, Compliance & Legal Affairs

“Great insight to hear payer perspective in contracting and account management and the changing healthcare landscape.”

Channel Liaison

“It was definitely an excellent well-rounded opportunity to meet new people, get new ideas, and get an in-depth education on what’s to come with the FDA collaborations.”

Quality Engineer
Centurion Medical Products

“It was very well organized event and high quality, the fact to have an IVD track was also interesting. Thanks, I will recommend the Q1 event!”

Regulatory Affairs – EMEA Regional Head

“The organization and support staff were fantastic! I’m looking forward to next year.”

Global Business Project Lead

About the Conference:

With the goal to swiftly release new products to the market, pharmaceutical and biotechnology regulatory publishing and submissions executives are challenged to present comprehensive and technically flawless product dossiers to regulatory authorities globally. The continued push for harmonized global regulations and impact of new technological capabilities has confronted regulatory operations executives with a multitude of hurdles to overcome while ensuring timely and compliant dossier submissions.

Topics to Be Addressed:

  • Rapid Submission Preparation through Project Management Excellence
  • Interpretation of Updates to Module 1 Submission Requirements
  • Use of Regulatory Information Management Systems in Submissions
  • Benefits of Increased Structured Data Submissions to Health Authorities
  • Reusable Submission Documents for Global Dossier Publishing
  • Enhancing Submission Dossier Quality through Stringent Review


75 Attendees

All attendees come directly from life science companies

Distinguished Presenters

18 Speakers


Networking time is built into the agenda to allow industry peers to connect and exchange ideas

Open Dialogue and Group Share

Each presentation is followed by 10-15 minutes of open dialogue for questions and exchange of best practices

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