Skip to main content
2021 PDA/FDA Joint Regulatory Conference Main banner
PDA
Amgen
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
  1. Home
  2. Full Schedule

Full Schedule

Full Schedule

  • Monday, September 27, 2021
  • 09:15 – 11:00 EDT
    Plenary 1: Opening Plenary

    Moderator: Francis RW Godwin, MBA – U.S. FDA

  • 11:00 – 11:30 EDT
    Virtual Exhibit Hall
    To visit the Exhibitors, click on the Exhibit Hall tile on the home screen.
  • 11:00 – 12:00 EDT
    Poster Presentations
  • 11:30 – 13:00 EDT
    Plenary 2: Emerging Stronger through Collaboration

    Moderator: Valerie Whelan – Thermo Fisher Scientific

    A wise man said that “Perseverance is not a long race; it is many short races one after the other.”

    Over the last eighteen months, we have won many of these short races together as we have adapted to the changing landscape driven by the pandemic. In this session we will hear from regulatory and industry leaders on those races; the practical challenges we have overcome from the simple to the complex, the transformative level of collaboration we have seen internally and externally, the innovation that we have accelerated and the changes that will enable us to emerge stronger.

  • 13:00 – 13:30 EDT
    Press Conference
  • 13:00 – 13:30 EDT
    Virtual Exhibit Hall
    To visit the Exhibitors, click on the Exhibit Hall tile on the home screen.
  • 13:30 – 15:00 EDT
    A1: Managing Investigations in a Global Network

    Moderator: Rick L. Friedman, MS – U.S. FDA

    Today’s global pharmaceutical supply chain typically includes many contributors to production of a drug. Strong quality system provisions and actions are needed when deviations, OOS results, or failures occur to ensure communications and close collaboration on investigations and resolutions. This session will address the attributes of quality systems that successfully manage cross-organizational investigations, with an emphasis on lessons learned and practical case studies.

    QUALITY ASSURANCE & QMS

  • 13:30 – 15:00 EDT
    B1: Supply Chain Collaboration and Product Approvals during a Pandemic

    Moderator: Paul Z. Balcer – U.S. FDA

    As treatments for COVID-19 infections were deployed during the pandemic, we were faced with challenges in drug supply of life saving medicines. Some countries enacted export bans of certain drugs, and other factors including plant staffing caused strains on the existing supply chains of APIs, raw materials, and finished drug products. Pandemic travel bans limited inspections of drug manufacturing facilities. We will examine the effect of the pandemic on drug supply chain and drug applications. The session will include regulatory experiences with EUAs and how use of tools such as remote assessments provided insight into facilities named in drug applications.

    SUPPLY CHAIN & MANUFACTURING CHALLENGES

  • 13:30 – 15:00 EDT
    C1: Holistic Capacity Planning: Best Practices and Lessons Learned from New Therapeutic Modalities

    Moderator: Ingrid Markovic, PhD – U.S. FDA

    Sudden onset of market and public health demands during in the face of global pandemic could lead to major capacity crunches causing production delays and/or unintended product quality outcomes. Holistic evaluation of process, facility, and operational requirements to identify potential bottlenecks is critical when planning for projected commercial manufacturing expansion (scale-up or scale-out) to ensure timely delivery of transformative therapies to patients with consistent product quality. Rapid advancement of C>s products and COVID-19 vaccines necessitated implementation of flexible and sustainable operational and facility designs. These could offer valuable learnings with operational aspects of individualized therapies possibly as challenging as those for the off-the-shelf products.

    EMERGING TRENDS & INNOVATION

  • 15:00 – 15:30 EDT
    Connect & Network
  • 15:00 – 15:30 EDT
    Virtual Exhibit Hall
    To visit the Exhibitors, click on the Exhibit Hall tile on the home screen.
  • 15:30 – 17:00 EDT
    Ask the Regulators: Inspection-Based
    U.S. FDA investigators, reviewers, and compliance officers will answer your questions in this Q&A session that will provide you with insights regarding current topics and initiatives.
  • 15:30 – 17:00 EDT
    Ask the Regulators: Review-Based
    U.S. FDA investigators, reviewers, and compliance officers will answer your questions in this Q&A session that will provide you with insights regarding current topics and initiatives.
  • 17:05 – 17:30 EDT
    Faramarz test session

    Presenter: Faramarz Kolivand, PhD – PDA Web Developerrrrrrrrrrrr