New York Professional Events List


Biosimilar from Development to Registration


Date
Jun 29, 2017 - 09:00 AM - Jun 30, 06:00 PM
Organizer
Global Compliance Panel
Location
Hilton Garden Inn Salt Lake City Airport 4975 Wiley Post Way, Salt Lake City, UT 84116, USA,

Salt Lake City,
UT,
US,
ZIP: 84116
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


Speaker Details


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.


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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