• Risk Management
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    Combination Products

    Start Date : October 18, 2018
    End Date : October 19, 2018
    Time : 9:00 am to6:00 pm

    Phone : (800) 447-9407
    Email : globalcompliancepanel@gmail.com

    Location :
    Courtyard Arlington Crystal City/Reagan National Airport 2899 Jefferson Davis Highway Arlington, VA 22202 USA

    Website

    Description



    Course "Combination Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


    Description:


    This seminar provides Professionals working in this area with:


    ·         A thorough understanding of the complexities involved


    ·         Covers all the relevant regulations and guidelines


    ·         Gives real life examples of how to register and maintain various types of combination products


    ·         Interfaces: Change Management and LCM


    ·         Compliant safety reporting for combination products


    ·         Documentation requirements and interfacing


    Why you should attend:


    Combination products are especially challenging to register and maintain since they consist of two or more regulated components covered by different and usually independent sets of regulations in both the EU and US and various other regions.


    Delegates working in this area must keep abreast of current and new legislation in this complex area to ensure a good regulatory strategy and compliance of their products.


    Areas Covered in the Session:


    Documentation requirements and interfacing


    ·         Documentation requirements for combination products EU


    ·         Documentation requirements for combination products US


    ·         Interfacing, development, quality, regulatory


    ·         Managing third parties and document control.


    Who will benefit:


    ·         Regulatory Affairs


    ·         Medical Officers


    ·         Clinical Trial Managers


     


    Agenda:


    Day 1 Schedule




    Lecture 1 (90 Mins):


    A high level overview to Combination Products


    Including an interactive group session reviewing individual expectations




    Lecture 2 (90 Mins):


    Introduction to Drug/Device Regulations


    During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities. Regulatory Requirements for: US and EU




    Lecture 3 (90 Mins):


    CE Marking, 510 K and PMAs general Overview


    ·         US and EU


    Life Cycle Management


    ·         Interfaces: Change Management


    ·         CTA applications


    ·         Annual reporting




    Lecture 4 (90 Mins):


    CASE STUDY 1 -


    Including a walkthrough of expected outcomes for all case study exercises


    Wrap up of day 1 & Q&A's 


     Day 2 Schedule




    Lecture 1 (90 Mins):


    Overview Combination product Regulation and CTD dossier requirments:


    EU and US (A comparative review)




    Lecture 2 (90 Mins):


    Clarifying the regulatory requirements of combination products and addressing life-cycle management


    ·         Examining the regulatory requirements for drug device combinations in the case of a drug and a device and for integral products


    ·         Annual reports


    ·         Case studies




    Lecture 3 (90 Mins):


    CASE STUDY 2




    Lecture 4 (90 Mins):


    Compliant safety reporting for combination products


    ·         Taking into account your product's combined components when addressing adverse event reporting




    CASE STUDY 3


    Wrap up of day 2


    Final Q&A & Summary of 'working smart' with Combination Products



    Speaker:


    Salma Michor,


    PhD, MSc, MBA, CMgr, RAC


    Salma Michor is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King's College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.


     


     


    Location:  Washington, DC Date: October 18th & 19th, 2018 and Time: 9:00 AM to 6:00 PM


    Venue:  Courtyard Arlington Crystal City/Reagan National Airport 
    2899 Jefferson Davis Highway Arlington, VA 22202 USA


     


    Price:


    Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You S        ave: $5,828.00 (45%)* Register now and save $200. (Early Bird)


    Sponsorship Program benefits for seminar


    For More Information- https://www.globalcompliancepanel.com/control/sponsorship


    Contact us today!


    NetZealous LLC DBA GlobalCompliancePanel


    john.robinson@globalcompliancepanel.com


    Toll free: +1-800-447-9407


    Phone: +1-510-584-9661


     Website: http://www.globalcompliancepanel.com


     


    Registration Link https://www.globalcompliancepanel.com/seminar/combination-products-901909SEMINAR?seo


    Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/


    Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/


    Follow us on Twitter: https://twitter.com/GCPanel


     


     


     




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    Registration Info

    https://www.globalcompliancepanel.com/seminar/combination-products-901909SEMINAR?meetings4docs-oct-seo

    Contact the Organizer

    Organized by

    Organized by globalcompliancepanel

    NetZealous LLC DBA GlobalCompliancePanel ,
    161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

    GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

    GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

    GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:

    • Risk Management
    • Regulatory Compliances
    • Corporate Governance
    • Quality Management
    Tel: 800-447-9407
    Email: globalcompliancepanel@gmail.com
    Website: https://www.globalcompliancepanel.com/seminar/combination-products-901909SEMINAR?meetings4docs-oct-seo


    Event Categories: Emergency Medicine.




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