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How to Master EU Interest Representation: The BM guide to EU lobbying best practices Webinar Time: 07:00 AM - 08:00 AM,Presentor: European Training Academy,Charges: Free
Survey of EU affairs professionals and European officials
What works best in lobbying: methods, tools, channels
Exclusive insights and presentation of the 2013 guide
Karen Massin joined Burson-Marsteller Brussels in August 2000 after having worked in DG External Relations at
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Survey of EU affairs professionals and European officials
What works best in lobbying: methods, tools, channels
Exclusive insights and presentation of the 2013 guide
Karen Massin joined Burson-Marsteller Brussels in August 2000 after having worked in DG External Relations at the European Commission. At Burson-Marsteller Brussels, Karen is Chief Operating Officer, her responsibility is to advise the wide variety of clients on EU policy developments such as environment, consumer affairs, energy and IT.
June 13 : Webinar on Highlights of 2013 registration status of biosimilars in the EU Webinar Time: 02:00 PM - 03:00 PM,Presentor: Dr. Hoss A Dowlat, RA,Charges: 299 USD US Dollar
Short Abstract:
There will be an insightful presentation as follows. EU patients, regulators, and industry have 6 unique years of experience of the basis of approval and medical use of the new class of medicines, the biosimilars. They have major economic impact. Also, they are safe and effect
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Short Abstract:
There will be an insightful presentation as follows. EU patients, regulators, and industry have 6 unique years of experience of the basis of approval and medical use of the new class of medicines, the biosimilars. They have major economic impact. Also, they are safe and effective when a patient begins a treatment, or is switched from originator medicines. In 2012 and 2013 new EU decisions, guidelines and policies are emerging that will have high impact on biosimilar approvals and prove far reaching.
The presentation will cover the following areas:
Advances in CHMP/ EMA scientific advice to industry on biosimilars, and EMA assessment/review practices
Unfolding of new product specific guidelines & 2012/2013 updates of overarching biosimilar guidelines
Expected impact of dramatic new EMA policy of the acceptance of a foreign reference medicinal product
First steps towards harmonization of EMA and FDA development of biosimilars
Latest experience with the recognition & acceptability of biosimilars among the medical community & penetration of European biologics market
Who Should Attend:
CEOs, VPs, Directors, Heads, Managers working within:
Evaluating the pathway for registration of Biosimilars in USA to gain swift product approvals Webinar Time: 02:00 PM - 03:00 PM,Presentor: Dr. Hoss A Dowlat, RA,Charges: 299 USD US Dollar
Past experiences of FDA regarding 10-20 year life cycle changes of biologics has paved the way to entering into biosimilars – a new paradigm is emerging. In spite of the rich and varied European experience the FDA takes its own unique course. FDA advisory style meetings in a first step woul
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Past experiences of FDA regarding 10-20 year life cycle changes of biologics has paved the way to entering into biosimilars – a new paradigm is emerging. In spite of the rich and varied European experience the FDA takes its own unique course. FDA advisory style meetings in a first step would determine eligibility of a new biosimilar candidate and for further meetings fees are charged as part of the new BsUFA . What genuine opportunities are there for harmonised US/EU and worldwide development? The selection of reference product dosage form and presentation has become more strategic than in the past years. Controversies towards regulatory clinical milestones need also to be crtically considered.
The presentation will cover the following areas:
Interpreting the New FDA Rules and ‘Stepwise’ approach to demonstrating biosimilarity
Consequential strategies for process development and manufacturing of biosimilars
Comparisons of the European regulatory standards, with 6 years of approved use of biosimilars, and FDA requirements
Opportunities and pathways towards harmonizing of FDA and EMA biosimilars development, including the choice of reference products
