3D Tissue Models
Combination Products 2017

Boston, MA

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.

This seminar provides Professionals working in this area with
•	A thorough understanding of the complexities involved
•	All the relevant regulations and guidelines
•	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


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
•	US and EU
Life Cycle Management
•	Interfaces: Change Management
•	CTA applications
•	Annual reporting
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
•	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:
Lecture 4:
Compliant safety reporting for combination products
•	Taking into account your product's combined components when addressing adverse event reporting
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.
Wrap up of day 2
Final Q&A & Summary of 'working smart' with Combination Products

Location: Boston, MA Date:  September 28th & 29th, 2017 and Time: 9:00 AM to 5:00 PM
Venue:   Embassy Suites Boston Logan Airport   207 Porter Street Boston, MA 02128


Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until August 10, Early Bird Price: $1,295.00 From August 11 to September 28, Regular Price: $1,495.00
Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. 
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. 
For More Information- https://www.globalcompliancepanel.com/control/sponsorship  
Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
 Website: http://www.globalcompliancepanel.com

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901066SEMINAR?biotechsciencenews-September-2017-SEO

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Schedule of Presentations:

Thursday, September 28, 2017
Friday, September 29, 2017
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