Workshop
on Biosimilars (14-15 February 2008)
This Workshop on Biosimilars was held from 14th to
15th February 2008 at the Kuala Lumpur Convention Centre
and was organized by the Legal & Regulatory Department
of BiotechCorp. The workshop was opened by Razif Abdul
Aziz, Vice President of Legal & Regulatory, BiotechCorp.
The workshop attracted around 100 participants from
the pharmaceutical (local and MNC) and biotech industry,
regulators from the National Pharmaceutical Control
Bureau, from universities as well as one keen biotech
manufacturer from India. The two-day workshop was the
first conducted on biosimilar by BiotechCorp.
The workshop was aimed at creating awareness and
understanding on the requirements for registering a
biosimilar product and similar biological medicinal
products globally as well as on all the regulatory
implications of process change and how to develop
regulatory compliance strategies. Featuring case studies
and interactive sessions, this workshop provided a guide
to finding the best ways to satisfy the needs of the
regulators and understand how various process changes
may impact the success of a biosimilar product.
Mr Cecil Nick, Principal Consultant, PAREXEL
Consulting, UK was the sole presenter for the two full
day workshop. Mr Nick has more than 25 years of
experience in regulatory affairs and worked for various
Bio/pharmaceutical and healthcare companies including
Novo Nordisk, Lundbeck, LIG, May & Baker and Farmitalia.
Mr Nick has extensive experience in the development and
EU registration of biotechnology and blood products,
devices, new chemical entities, orphan drugs, EU
marketing regulations and scientific advice. He
diligently responded to all queries pertaining to the
regulations.
Key topics covered:
- Biologicals introductory
- Spectrum of complexity
- Immunogenicity
- Comparability assessment
- Demonstration of similarity
- EU Regulations relating to biosimilars
- EU Guidelines and quality data requirements
- Clinical & non-clinical developments
- Case study
- Commercial considerations
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