New York, NY, November 23, 2016 --(PR.com
)-- The Knowledge Group/The Knowledge Congress Live Webcast Series, the leading producer of regulatory focused webcasts, has announced today that Gareth Morgan, Partner with Olswang LLP will speak at The Knowledge Group’s webcast entitled: “Biosimilars Regulatory and Legal Challenges: A Look Back and What’s Ahead.” This event is scheduled for December 8, 2016 from 12:00pm – 2:00pm (ET).
For further details, please visit: https://theknowledgegroup.org/event-homepage/?event_id=2001
About Gareth Morgan
Gareth is a qualified solicitor admitted to the Roll in England (and Wales) and Ireland. He obtained a first class degree from Oxford University in Biochemistry, and his PhD was carried out at the Dunn School of Pathology in Oxford in molecular genetics. Gareth has acted in many landmark UK IP trials concerning patent entitlement, biotechnology patent validity and infringement, SPCs (including EU Court of Justice references) and the interpretation of IP licences. He has also represented clients before the English Administrative Court and EU Courts in relation to challenges around marketing authorisation procedures.
Gareth has advised pharmaceutical and biotechnology clients on aspects of patent portfolio strategy, orphan exclusivity, paediatric exclusivity, Biosimilar applications, centralised procedure applications, interpretation of the medicines directives and associated guidance. Gareth also provides legal and technical advice concerning CHM appeals, agency scientific advice meetings and CHMP referrals and information meetings.
Gareth provides advice to clients on matters of governmental affairs drawing on his IP and medicines regulatory experience.
About Olswang LLP
Olswang LLP is an international law firm and a European and Asian leader in Technology, Media and Telecommunications. It also has established a commanding reputation for changing the face of business in a wide range of other industries, from Real Estate and Retail to Life Sciences and Leisure. Its partnership spans seven international offices across Belgium, France, Germany, Spain, the UK and Singapore, and, together with it 'best friends' network of leading independent law firms, it advises clients across EMEA, the US and South-East Asia.
The development of biosimilars in the different regions of the globe is increasing at a rapid pace. Biosimilars offer improved access to effective biological therapies at reduced costs, the reason why it garnered great interest among industry, regulators and consumers. At this point, many pharmaceutical companies are looking for guidance in understanding the regulatory and legal landscapes of biosimilars in the United States, in Canada and in Europe.
In this two-hour live Webcast, a panel of distinguished professionals and thought leaders organized by The Knowledge Group will provide an in-depth discussion on the regulatory and legal developments that biosimilar applications should know. The speakers will share practical advice to succeed in this rapidly developing area of the pharmaceutical industry.
Some of the major topics that will be covered in this course are:
- Biosimilar Legislation in the US
- The Purple Book of Biosimilars
- US Approval Pathways
- Interchangeability Requirements
- Status of Subsequent Entry Biologics (SEB) in Canada
- Clinical Studies and Post-Market Requirements
- Existing Guidelines in Europe
- Review of Approvals in Europe
- Recent Regulatory and Legal Updates
About The Knowledge Group/The Knowledge Congress Live Webcast Series
The Knowledge Group was established with the mission to produce unbiased, objective, and educational live webinars that examine industry trends and regulatory changes from a variety of different perspectives. The goal is to deliver a unique multilevel analysis of an important issue affecting business in a highly focused format. To contact or register for an event, please visit: http://theknowledgegroup.org/