How to Register and Maintain Several Types of Combination Products | Seminar 2018

Start Date : June 25, 2018
End Date : June 26, 2018
Time : 9:00 am to6:00 pm

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

Location :
Hilton Garden Inn O'Hare 2930 S. River Road Des Plaines, IL 60018

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.


Overview:


This seminar provides Professionals working in this area with:



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



Who will benefit:



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



Life Cycle Management





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





Lecture 3(90 Mins):


CASE STUDY 2




Lecture 4(90 Mins):


Compliant safety reporting for combination products



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:  Chicago, IL Date: June 21st & 22nd, 2018 and Time: 9:00 AM to 6:00 PM


Venue:  Hilton Garden Inn O'Hare 2930 S. River Road Des Plaines, IL 60018


Price:


Price: $1,495.00 (Seminar Fee for One Delegate)


Register for 5 attendees Price: $4,485.00 $7,475.00 You Save: $2,990.00 (40%)*


Register for 10 attendees Price: $8,222.00 $14,950.00 You Save: $6,728.00 (45%)*


Sponsorship Program benefits for “Combination Products” 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/control/globalseminars/~product_id=901612SEMINAR?SEO


 


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Registration Info

https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901612SEMINAR?meetings4docs_june_2018_seo

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous LLC DBA GlobalCompliancePanel ,
161 Mission Falls Lane,suite 216

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.

Tel: 8004479407
Mobile: 8004479407
Email: globalcompliancepanel@gmail.com
Website: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901612SEMINAR?meetings4docs_june_2018_seo


Event Categories: Health & Nutrition and Physical Medicine.




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