Combination Products Regulations Course | USA & EU Seminar 2018

Start Date : May 15, 2018
End Date : May 16, 2018
Time : 9:00 am to5:00 pm

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

Location :
Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

Website

Description

Course "Combination Products Regulations: Drug and Device Combinations in the USA and EU" 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:



Day 1 Schedule




Lecture 1:


A high level overview to Combination Products


Including an interactive group session reviewing individual expectations




Lecture 2:


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:


CE Marking, 510 K and PMAs general Overview



Life Cycle Management





Lecture 4:


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:


Overview Combination product Regulation and CTD dossier requirments: EU and US (A comparative review)




Lecture 2:


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





Lecture 3:


CASE STUDY 2




Lecture 4:


Compliant safety reporting for combination products



Documentation requirements and interfacing





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:  Zurich, Switzerland Date: May 15th & 16th, 2018 and Time: 9:00 AM to 5:00 PM


Venue:  Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland


Price:


Price: $1,695.00 (Seminar Fee for One Delegate)


Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*


Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)*


Register now and save $200. (Early Bird)


Until April 10, Early Bird Price: $1,695.00 From April 11 to May 13, Regular Price: $1,895.00


Sponsorship Program benefits for “Combination Products Regulations Course | USA & EU Seminar 2018” seminar


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


Contact us today!


NetZealous LLC DBA GlobalCompliancePanel


john.robinson@globalcompliancepanel.com  


support@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=901483SEMINAR?SEO


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


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Registration Info

Registration link :  https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901483SEMINAR?may-2018-seo-meetings4doc

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.

Tel: 800-447-9407
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com/


Event Categories: Business Practice and General Surgery.

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