New York Professional Events List


Biosimilar from Development to Registration


Date
Aug 03, 2017 - 09:00 AM - Aug 04, 06:00 PM
Organizer
Global Compliance Panel
Location
Courtyard by Marriott Raleigh-Durham Airport/Morrisville 2001 Hospitality Ct, Morrisville, NC 27560, USA,

Morrisville,
NC,
US,
ZIP: 27560
Phone: 1 929 900 1853

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
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Please contact the event manager Marilyn below for the following:
- For Registrations Please call +1 929.900.1853
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
 
NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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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
 

Event Categories
BUSINESS & MANAGEMENT CONFERENCES
,
HEALTH AND MEDICINE CONFERENCES
,
Healthcare
,
Life Sciences, Biotechnology
,
SCIENCE AND TECHNOLOGY CONFERENCES
,
Technology
Keywords: fun, access , Clinical , design , development , Fun , iOS, professional, purchase, technical




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