Webcast: RAC (US) Exam Preparation Series (2016)




  • Objectives & Audience
  • Agenda
  • Speakers
  • Registration Info
  • How does it work?

Learning Objectives

This popular webcast series serves as a study tool for individuals preparing for the RAC (US) Exam.

    Who Should Attend

    • Those who have registered or plan to register for the RAC (US) Exam
    • Regulatory professionals of all levels wishing to expand their knowledge

    RAC Credits: 11 

    Agenda

    Clinical Considerations I & II

    • History/Evolution of Clinical Trials (brief overview)
      • Code of Research Ethics (Nuremberg, Helsinki, Belmont)
      • Code of Federal Regulations (CFR)
    • DRUGS
      • Clinical Trial Types Phase 1-4
      • Good Clinical Practices/Institutional Review Boards (GCPs/IRBs)
      • Safety Reporting for Investigational New Drug (IND), Bioavailability and Bioequivalence Studies
      • Sponsor Responsibilities
      • Expedited Development
      • Post Approval Activities
      • Risk Management
    • DEVICES: Clinical Trial Types
      • Design Features
      • Phase 1-4
    • DEVICES: Quality Assessment
      • Corrective and Preventive Action (CAPA)
      • Safety Reporting for Devices: Medical Device Reporting/Safe Medical Device Act (MDR/SMDA)
      • GxPs
      • Audits

    Medical Devices I & II

    27 July

    • History of Regulations
    • Regulatory Framework for Devices
      • What is a medical device
      • Who regulates medical devices
      • Classification/reclassification
      • How to determine classification
      • General controls
      • Special controls for Class II devices
      • Premarket approval for Class III devices
    • Regulatory Submissions
      • Premarket notification 510(k)
      • De novo
      • Investigational Device Exemption (IDE)
      • Premarket Approval (PMA)
      • Expedited Review
      • Humanitarian Device Exemption (HDE)

    3 August

    • Agency Interaction
    • Quality System Regulation
    • Labeling Requirements
    • Postmarket Surveillance/Medical Device Reporting (MDR)
    • Recalls, Corrections, and Removals
    • Promotion and Advertising
    • Import/Export
    • In Vitro Diagnostics (IVD)

    Pharmaceuticals I & II

    10 August

    • Introductions and General Principles
    • Overview of the Drug Development Continuum
    • FDA Meetings
    • Investigational New Drug (IND) Requirements and Submissions
    • Special Protocol Assessments
    • IND Maintenance
    • New Drug Application (NDA) Requirements and Submissions
    • Prescription Drug User Fee Act (PDUFA) Fees and Approvals
    • 505(b)(2) NDAs
    • NDA/ANDA Maintenance and Postapproval Activities

    17 August

    • Overview of Over-the-Counter Drug Products
    • Abbreviated New Drug Application (ANDA) Requirements and Submissions
    • Suitability Petitions
    • Generic Drug User Fee Amendments (GDUFA) Fees and Approvals
    • Comparability Protocols
    • Expedited Approval Pathways
    • Orphan Drug Designation
    • Pediatric Research Equity Act (PREA) Requirements
    • Good Manufacturing Practices (GMPs)

    Biologics

     TBA

    Speakers

     

    13 & 20 July:Clinical Considerations I & II12:00-1:30 pm ET

    Robert Rogers, RAC, director, regulatory affairs & quality systems, NDI Medical

    Andrew S. Verderame, MBA, RAC, president, PharmaLex US

    27 July & 3 August:Medical Devices I & II12:00-1:30 pm ET

    Tricia Cregger, PhD, RAC, manager, STERIS Corporation

    Tony Piotrkowski, CQA, RAC, senior manager, STERIS Corporation

    10 & 17 August:Pharmaceuticals I & II12:00-1:30 pm ET

    William (Trey) Putnam, PhD, RAC, vice president & general manager, Cardinal Health

    David Silberstein, executive director, regulatory affairs, Valeant

    24 August:  Biologics12:00-2:00 pm ET

    Gilbert (Chip) Carnathan, PhD, RAC, director, Impact Pharmaceuticals

     

    Registration Info

    Live Webcast with On-demand Access:

    Register by 28 June: Member: $1,100 USD; List: $1,300 USD

    Register after 28 June: Member: $1,250 USD; List: $1,450 USD

    » Registration Form (PDF) - for registration by mail or fax.

    Cost is per site - unlimited participants. One login provided per registration. Duplicate logins will be removed from the webcast room.

    To register for individual sessions:

    13 & 20 July:Clinical Considerations I & II12:00-1:30 pm ET
    27 July & 3 August:Medical Devices I & II12:00-1:30 pm ET
    10 & 17 August:Pharmaceuticals I & II12:00-1:30 pm ET
    24 August:   Biologics12:00-2:00 pm ET

     

    Cancellation and Refund Policy

    Written cancellations received by 11:59 pm ET 28 June 2016 will be refunded the registration fee minus a $50 administrative fee.

    Online registration will close at 12:00 pm ET the day prior to the webcast. Individuals wishing to register after this time may register only by phone.

    Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.

    If you are not a member or an existing RAPS customer, you will need to create an account to purchase this item.

    How does it work?

    All you need to participate in a webcast is Internet access and a telephone connection. Expert presenters virtually deliver the presentation via the Internet, while participants simultaneously view the PowerPoint slides on their own computers. A live Q&A portion following the presentation enables interaction between participants and presenters. Please check the webcast schedule for exact event dates and times.