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Bethesda North Marriott Hotel and Conference Center

Feb 13, 2023 11:30 AM - Feb 15, 2023 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum


Short Course: February 9, 2023 | Virtual

Short Course: February 10, 2023 | Virtual

Primer: February 12, 2023 | In-Person

February 13-15: Forum

The last few years have shed light on the importance of operational efficiency of the management of regulatory information to ensure quality regulatory submission to health authorities. We have seen how the ability to perform at this level has allowed drug companies to bring therapeutics and vaccines to patients faster. At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum, we will hear from industry and regulatory stakeholders working across the scope of regulatory information to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related people, processes, and technology. The Forum presents four tracks: Regulatory Informatics Business, Regulatory Informatics Technology, Trial Master File (TMF) Inspection Readiness and Electronic Document Management, and Electronic Regulatory Submissions. Cross-track sessions provide the opportunity to discuss key connection points across major components of regulatory information, and plenary sessions featuring regulatory intelligence updates by FDA and other regulatory authorities are offered each day.

This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees.

Participant Testimonials

The forum was incredibly valuable in terms of meeting colleagues from around the world —industry and regulators — and collaborating on solutions to improve submission efficiency andmake data more readily usable. – Virginia Hussong, Chief Data Standards Program, CBDER, FDA

Fantastic forum! I am 17 years in the pharmaceutical industry, but new to the regulatory sector, and it was great to align my prior manufacturing knowledge to the regulatory area. Great event! All the right people, all in the right place! – Matthew Tyler, Director of Business Development, Qdossier, a Celegence Company

The breadth of subject matter expertise, and diverse perspectives make RSIDM a must attend event for anyone involved in Regulatory activities. – Gary Colantonio, MS, MBA, Associate Director, Regulatory Affairs, Merck & Co., Inc.

Need Approval in Order to Attend?

Download and fill out our Justification Letter to demand to supervisor why this is a must-attend event.

Keynote Address!

February 13 | 1:25-2:00PM

Keynote Address

Ulo Palm, MD, PhD, MBA Chief Medical Officer Vaxxinity


Want to learn more about Regulatory Submissions, Information, and Document Management Forum? You've come to the right site!

Continuing Education

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Highlights & Features

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What you will learn

What you will learn:

  • Medical Communications
  • Medical Writing
  • Medical Science Liaisons
  • Medical Information
  • Medical Call Center Environment
  • Regulatory Affairs
  • Clinical Research
  • Professional Education, Training, and Development
  • Document Management/eSubmissions

Who should attend?

Meeting Designed For:

  • Medical Communications
  • Medical Writing
  • Medical Science Liaisons
  • Medical Information
  • Medical Call Center Environment
  • Regulatory Affairs
  • Clinical Research
  • Professional Education, Training, and Development
  • Document Management/eSubmissions

Learning objectives

Learning Objectives

At the conclusion of this activity, participants should be able to:
  • Discuss the changing responsibilities of the scientific communications professional and explore the impacts to content creation, internal collaborations, patient engagement, and vendor management
  • Recognize the unique skill set needed to make a good medical writing, medical science liaison, and medical communication’s leader
  • Examine insights to the future of the medical science liaison (MSL)
  • Recognize the importance of insight generation
  • Identify opportunities for including the patient voice in medical writing activities
  • List regulations and guidelines that are essential and relevant for promotional materials
  • Identify opportunities for including the patient voice
  • Discuss the evolution and future of the clinical study report (CSR)
  • Describe how patient-facing digital therapies fit into the broader digital health technologies
  • Define how omnichannel applies to Medical Communications and MSL functions
  • Evaluate the process by which artificial intelligence can produce documentation for medical writing
  • Identify strategies to prepare for an audit or inspection and anticipate the requirements to pass them
  • Apply best practices for improved HCP access and ensure issues are addressed proactively

Register Now

Short Course or Primer

To keep you at the forefront.

Feb 12, 2023

Regulatory Content and Submission Primer:

Content from Authoring to Archive

Feb 09, 2023

Short Course:

The Future of Documents

Feb 10, 2023

Short Course:

On the Road to an EU Filing

Program Committee

  • Michiel  Stam
    Michiel Stam Director Regulatory Information Management
    Qdossier - A Celegence Company, United Kingdom
  • Karen  McCarthy Schau
    Karen McCarthy Schau Director, Risk-based Study Management
    Vertex Pharmaceuticals, United States
  • Stacy  Tegan
    Stacy Tegan Program Director
    Transcelerate Biopharma, Inc., United States
  • Ethan  Chen, MBA, MS, PMP
    Ethan Chen, MBA, MS, PMP Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
    FDA, United States
  • Jake  Doran
    Jake Doran Head of Digital
    Lykos Therapeutics, United States
  • Jo  English
    Jo English VP and General Manager, Enterprise Technology
    Calyx, United Kingdom
  • Vahe  Ghahraman, PhD
    Vahe Ghahraman, PhD Senior Director, Global Regulatory Operations Head
    Apellis Pharmaceuticals, Inc. , United States
  • Kristen  Sauter, MBA
    Kristen Sauter, MBA Senior Director, Head, Global RIM, Analytics & Digital Innovation
    Takeda Pharmaceuticals, United States
  • Cary  Smithson, MBA
    Cary Smithson, MBA Senior Director, Business Transformation & Systems Management
    Cencora Pharmalex, United States
  • Katherine  Novak, MS
    Katherine Novak, MS Principal Product Manager
    Accumulus Synergy, United States
  • Alison  Buno, MBA
    Alison Buno, MBA Senior Director, Regulatory Submissions
    AbbVie, Inc., United States
  • Joanne  Malia, MS, MSc
    Joanne Malia, MS, MSc Director, Development Records Management
    Regeneron Pharmaceuticals, United States
  • Jamie  O'Keefe
    Jamie O'Keefe Head, Clinical & Regulatory Consulting
    Astrix, United States
  • Joel  Finkle
    Joel Finkle Industry Expert
    Retired, United States
  • Sandra  Krogulski, MA
    Sandra Krogulski, MA Director, GRSO Innovation and Business Operations Lead
    Bristol-Myers Squibb Company, United States
  • Rob  Labriola, MS
    Rob Labriola, MS Exec. Director, Regulatory Operations
    Garuda Therapeutics, United States
  • Daniel  Offringa
    Daniel Offringa Principal Consultant
    eSub Solutions, United States
  • Jonathan  Resnick, PMP
    Jonathan Resnick, PMP Project Management Officer, OBI, OSP, CDER
    FDA, United States
  • Representative Invited
    Representative Invited DIA, United States

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