2-day In-person Seminar

Biosimilar from Development to Registration


August 3rd & 4th, 2017

Time: 9:00 AM to 6:00 PM

Raleigh, NC

Venue: Courtyard Raleigh-Durham Airport


Director : Salma Michor

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

  Price: $1,495.00
(Seminar Fee for One Delegate)

  Register for 5 attendees   Price: $4,485.00
      $7,475.00 You Save: $2,990.00 (40%)*

  Register for 10 attendees   Price: $8,222.00
      $14,950.00 You Save: $6,728.00 (45%)*
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.

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

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
Want to register by P.O/Check?
We facilitate registration by P.O/Checks!
Complete your registration in just a few easy steps
Please just download, fill out the registration form and send it to us either by email to support@globalcompliancepanel.com or just fax us at 302 288 6884.
Once the form is received, an invoice will be generated and sent back to your fax number.
Following this just send us your purchase order by fax at 302 288 6884
Click here to download Registration form
In case you wish to register by using check
In case you wish to register by using check, please make a check to NetZealous LLC DBA GlobalCompliancePanel.com and mail it to the below address.
NetZealous LLC,
DBA GlobalCompliancePanel,
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
Phone: 1800 447 9407

Want to register by Wire Transfer?
Please call any of our representatives on 1800 447 9407 to help you completed the transfer.
Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

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 Hotel: Courtyard Raleigh-Durham Airport   2001 Hospitality Ct, Morrisville, NC 27560, United States

Copyright © 2017 GlobalCompliancePanel. All rights reserved. Netzealous