Other related webinars
Essential Biosimilars Perspectives for Indian Ph...
Monday, 29th November, 2010
Time : 02:00 PM IST | 09:30 AM CET
Essential Biosimilars Perspectives for American ...
Thursday, 10th February, 2011
Time : 02:00 PM EST | 11:00 AM PST
Vital Perspectives on Monoclonal Antibody (mAB) ...
Monday, 18th April, 2011
Time : 02:00 PM | 11:00 AM
Essential Regulatory Perspectives and Best Clini...
Thursday, 15th September, 2011
Time : 02:00 PM IST | 09:30 AM CET
The strategic importance and key success factors...
Friday, 4th November, 2011
Time : 02:00 PM | 11:00 AM
Unwanted Immunogenicity of Biosimilars or follow...
Friday, 18th November, 2011
Time : 02:00 PM | 11:00 AM
A Glimpse of the Future - US Biosimilars Litigat...
Thursday, 15th December, 2011
Time : 02:00 PM | 11:00 AM
European approval of Biosimilar products – wha...
Thursday, 22nd December, 2011
Time : 02:00 PM EST | 11:00 AM PST
Progress report on Biosimilars including World...
Friday, 17th February, 2012
Time : 02:00 PM EST | 11:00 AM PST
Interpretation & insight into the FDA draft guid...
Friday, 2nd March, 2012
Time : 02:00 PM EST | 11:00 AM PST
FDA’s Current Thinking on Regulatory Path of B...
Friday, 16th March, 2012
Time : 02:00 PM EST | 11:00 AM PST
Comparing and contrasting FDA BIOSIMILARS guidan...
Friday, 27th April, 2012
Time : 02:00 PM EST | 11:00 AM PST
An overview of the newly released final 2012 EU ...
Wednesday, 25th July, 2012
Time : 02:00 PM EST | 11:00 AM PST
A EU/US Regulatory and Technical Practical Persp...
Friday, 31st August, 2012
Time : 02:00 PM EST | 11:00 AM PST
Assessing the Global Biosimilar Market
Friday, 5th October, 2012
Time : 02:00 PM EST | 11:00 AM PST
Harmonization in Biosimilars: EU and FDA Accepta...
Tuesday, 23rd October, 2012
Time : 02:00 PM EST | 11:00 AM PST
Scientific and Regulatory Issues in the Demonstr...
Friday, 14th December, 2012
Time : 02:00 PM EST | 11:00 AM PST
Biologics in a World with Biosimilars
Wednesday, 26th June, 2013
Time : 02:00 PM EST | 11:00 AM PST
Exploring latest FDA/EMA concepts of US-EU compa...
Friday, 15th November, 2013
Time : 02:00 PM EST | 11:00 AM PST
Executive Update of the US/EU status and opportu...
Wednesday, 27th May, 2015
Time : 02:00 PM EST | 11:00 AM PST
Biosimilar Orphan Drugs: The Next Regulatory Cha...
Friday, 21st October, 2016
Time : 01:00 PM EDT | 10:00 AM PDT
Unique executive perspectives into biologics and...
Friday, 25th November, 2016
Time : 02:00 PM IST | 09:30 AM BST
Biosimilars: Key factors for successful uptake i...
Friday, 3rd February, 2017
Time : 01:00 PM EST | 10:00 AM PST
Biosimilars Advances in the Approvals of Biosimi...
Thursday, 7th September, 2017
Time : 01:00 PM EST | 10:00 AM PST
FDA - Important Aspects to Consider When Determi...
Friday, 20th October, 2017
Time : 01:00 PM EST | 10:30 AM PST
Pitfalls in the Analytical Characterization of B...
Friday, 22nd December, 2017
Time : 01:00 PM EST | 10:30 AM PST
Understanding Bioavailability And Bioequivalence...
Wednesday, 28th March, 2018
Time : 01:00 PM EST | 11:30 AM BST
FDA Interchangeability Requirements for Biosimil...
Thursday, 19th April, 2018
Time : 01:00 PM EST | 10:00 AM PST
Executive insights into the FDA "Purple Book" Cl...
Friday, 17th July, 2020
Time : 01:00 PM EST | 11:30 AM BST
Evaluating the pathway for registration of Biosi...
Friday, 23rd September, 2022
Time : 01:00 PM EST | 10:00 AM PST
Recorded Webinar
Essential Regulatory Perspectives and Best Clinical and Nonclinical Practices for Indian Pharma Companies Vital to EU MAA and US NDA/BLA Marketing Approvals/Authorisations of Innovative, Biosimilar and Generic Medicines
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
This presentation will provide unique and fresh insights, and perceptives into the data capture and reporting requirements for the nonclinical and clinical development of small molecules, biologics and biosimilars. Important is not only the right information, but recognition that a study can be grossly undermined by wrong comparators, or poor, incomplete or inaccurate presentation of reports or location (medical practice, ethnicity, compliance). Is it relevant if the nonclinical and clinical study are pivotal to future marketing authorization? Warning: you think you have done a good job; BUT you have actually made decisive regulatory mistakes:
Precautions to act on, also Points to Consider:
- Design the studies with the correct arms including attention to reference medicinal products and placebo.
- Be aware that GCP, GLP and GMP compliance is only the basic requirement. It is a starting point; in fact, the quality of the study is critical. Even when India constitutes one arm of a multicentre clinical study.
- Pay attention to how and what raw data is captured.
- Establish SOPs and prove their practical implementation.
- Address the problems associated with the common practice of study connected Indian staff leaving at different levels of seniority.
- Ensuring internal and sponsor audits.
- Preparing for agency inspections.
- Tackling new kind of studies, innovations, where prior experience did not exist at CRO. Associated practical issues.
- Writing of reports of acceptable standard, not only ICH. A good clinical or nonclinical study being undermined by a poor report. Understanding specific requirements for eCTD.
- Alert to Indian regional specific difference of outcome due to ethnicity ICH E-5, (intrinsic/extrinsic factors) adverse drug events.
- Experience of differences between EU and US requirements.
European and American experience of the presenter permits identifying success factors for medicines development internationally. The presenter has had major submission and approval experience in the EU and USA, and has insights into the approvability of products based on study designs and data presentation. He has been engaged in consulting for a number of companies in the full development of drugs and biologics, generic, biosimilars and innovative. The lessons learned will be shared with delegates and practical tips will be provided. Therefore, the pitfalls that can be anticipated and the proactive measures taken to avoid them will be addressed from both a European and International perspective. Safety considerations, which are uppermost in the regulators, mind will be highlighted, including immunogenicity effects.
A variety of tips will be provided to increase the sponsors or the clients chances of marketing approval success and reduce overall risk to the programme. To conclude, the presentation and follow up discussion will identify success factors for drug or biologics development in an international setting.
Who should attend
- Head/VP/Director of R&D Pharmaceutical/Biotechnology.
- VP / Director of QA
- Clinical Operations.
- Green chemistry professional/Consultant
- Director regulatory clinical Quality and Regulatory
- VP / Director of Pharmaceutical/Healthcare/Biotechnology
Content Disclaimer
Contents in our website are from external websites. Links to and content from external website are provided for the convenience of users. Biopractice.com takes no responsibility for the content of such links and websites.