Biosimilar from Development 2017 - Biosimilar from Development to Registration 2017

Course "Biosimilar from Development to Registration" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes:
• Design and TPP
• Pre-clinical testing and comparability
• Clinical testing
• Analytical studies
• Stability of biosimilar products
Why you should attend:
The regulation of Biosimilars is very complex and the approach used by various regions differs. Professionals working in this complex area should be equipped with the latest knowledge and keep abreast of current and new legislation and requirements in this field in order to gain market access for their products.
Areas Covered in the Session:
his course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes:
• Design and TPP
• Pre-clinical testing and comparability
• Clinical testing
• Analytical studies
• Stability of biosimilar products
Who Will Benefit:
• Regulatory Affairs
• Medical Officers
• Clinical Trial Managers
Agenda:
Day 1 Schedule
Lecture 1:
Biosimilars challenges and choices
• Definitions
• Risks and benefits
• Historical development
• Regulatory landscape
Lecture 2:
Biosimilars legislation in the EU and the US
• EU legislation
• US legislations
•
Lecture 3:
Establishing your TPP
TPP for your Biosimilar
Pre-clinical aspects
Comparability and characterization
Pre-clinical testing
Lecture 4:
Important guidelines
Quality
Stability
Pre-clinical testing
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:
Clinical aspects
Phase I
Phase III
Lecture 2:
Important guidelines
Clinical testing
Safety
Lecture 3:
Registration process EMA
Walk through the EU Centralized registration process
What to look out for
Project management
Lecture 4:
Market access for Biosimilars
HTA in Europe/US
CASE STUDY 2 � Including a walkthrough of expected outcomes for all case study exercises
Wrap up of day 2 & Q&A's
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: Raleigh, NC Date: August 3rd & 4th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Courtyard Raleigh-Durham Airport 2001 Hospitality Ct, Morrisville, NC 27560, United States
Price:
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until June 20, Early Bird Price: $1,295.00 From June 21 to August 01, 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.
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