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Conversation Starters

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Conversation Starters – New for 2023!
Sessions tagged as “Conversation Starters” are main conference sessions that offer a Solutions Circle (which may occur before or after main session) that takes a deeper dive of its topic. Attendance of the main conference session is not required to attend the Solutions Circle.

*Program and facilitators subject to change. Please check back frequently for updates.

Conversation Starters

  • Wednesday, Oct 4th
    8:00 AM - 9:15 AM EDT
    Unlocking Opportunities for Entry-Level Positions in Regulatory Affairs
    Location/Room: 513F
    Moderator: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
    Presenter: Brittany Caldwell
    Presenter: Ritu Dhami – Network Partners Group
    Presenter: Grace Gowda, M.Pharm., PhD, RAC – University of Georgia
    Presenter: Elena Kyria – Elemed
    Presenter: Brian Savoie – RAPS
    Skill Building
  • Wednesday, Oct 4th
    12:45 PM - 1:15 PM EDT
    Solutions Circle: Regulatory Intelligence Solutions Circle
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Rosanne Middleton – Lifescan
    Facilitator: Dinar Suleman, RAC – Lifescan
    Solutions CircleSkill Building
  • Wednesday, Oct 4th
    2:00 PM - 3:00 PM EDT
    Seven Key Qualities of a Successful Regulatory Leader and How to Develop Them
    Location/Room: 513F
    Session Leader: Monika McDole-Russell, MS, RAC – Medtronic Endoscopy
    Moderator: Amra Racic – Veeva Systems
    Skill Building
  • Wednesday, Oct 4th
    3:30 PM - 4:30 PM EDT
    The Future of Regulatory Affairs In An Everchanging World
    Location/Room: 513F
    Session Leader: Aman Khera, EMBA, FRAPS, FTOPRA – Worldwide Clinical Trials
    Presenter: Linda Bowen, MSc, RAC, FRAPS – Seagen Inc.
    Skill Building
  • Thursday, Oct 5th
    11:25 AM - 11:55 AM EDT
    Solutions Circle: How to Improve Your Regulatory Interactions by Practicing Speaking and Active Listening Skills
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Yoshiko Stowell, PhD – Neuron23, Inc.
    Facilitator: Susan E. Carino, FRAPS, MBA, MS, PMP, RAC, SSM – Integrated Project Management Company, Inc.
    Solutions CircleSkill Building
  • Thursday, Oct 5th
    12:05 PM - 12:35 PM EDT
    Solutions Circle: The Journey to RAC!
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Rani Maloney, MBA, PMP, RAC – Integrated Project Management
    Facilitator: Gregory L. Palagi, PMP DASM CSM – Integrated Project Management, Inc.
    Facilitator: Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS
    Solutions CircleSkill Building
  • Thursday, Oct 5th
    12:05 PM - 12:35 PM EDT
    Solutions Circle: Transparent, Translucent, and Opaque: How Global Health Authorities Make Information Publicly Accessible
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Chris Whalley, cwhalley@seagen.com – Seattle Genetics
    Solutions CircleSkill Building
  • Thursday, Oct 5th
    12:45 PM - 1:15 PM EDT
    Solutions Circle: Using Situational Leadership to Manage Yourself and Others
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Jacqueline Torfin – Quality and Regulatory Expert Partners, LLC
    Solutions CircleSkill Building
  • Thursday, Oct 5th
    2:00 PM - 3:00 PM EDT
    Importance of Building Relationships with Health Authorities: Case Study for NDA Review of Orphan Product
    Location/Room: 510B
    Presenter: AJ Acker – Annexon Biosciences
    Presenter: Kunal Kanani, PharmD, MBA – Annexon Biosciences
    Presenter: Mary Jo Salerno, MS PT, MPH – US Food and Drug Administration
    Presenter: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
    Skill Building
  • Thursday, Oct 5th
    3:30 PM - 4:30 PM EDT
    Live LinkedIn Feedback Session
    Location/Room: RAPS Store Stage (Level 2 Registration Foyer)
    Presenter: Elena Kyria – Elemed
    Skill Building
  • Thursday, Oct 5th
    3:30 PM - 4:30 PM EDT
    The Art of Submission Planning: From Strategy to Filing
    Location/Room: 513F
    Skill Building
  • Thursday, Oct 5th
    4:45 PM - 5:45 PM EDT
    Financial Acumen for Regulatory Affairs
    Location/Room: 513F
    Session Leader: Megha Iyer, MS, RAC – Thermo Fisher Scientific
    Presenter: Bill McMoil – Regulatory Affairs Professionals Society (RAPS)
    Presenter: Susan Speicher, MS – UpToDate, Inc.
    Skill Building