Sign for Notice Everyday    Sign Up| Sign In| Link| English|

Our Sponsors

    Receive Latest News

    Feedburner
    Share Us


    Seminar on Combination Products at Salt Lake City

    View: 59

    Website https://www.globalcompliancepanel.com/seminar/combination-products-901906SEMINAR?ourglocal-Oct-SEO-2 | Want to Edit it Edit Freely

    Category Regulatory Affairs, Medical Officers, Clinical Trial Managers, compliance seminars

    Deadline: October 13, 2018 | Date: October 15, 2018-October 16, 2018

    Venue/Country: Hilton Garden Inn Salt Lake City Airport 4975 Wi, U.S.A

    Updated: 2018-09-11 19:20:31 (GMT+9)

    Call For Papers - CFP

    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: Salt Lake city, UT Date: October 15th & 16th, 2018 and Time: 9:00 AM to 6:00 PM

    Venue: Hilton Garden Inn Salt Lake City Airport 4975 Wiley Post Way, Salt Lake City, Utah, 84116, 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 Save: $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.robinsonatglobalcompliancepanel.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-901906SEMINAR?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


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.