Other related webinars
Essential Regulatory Perspectives and Best Clini...
Monday, 7th February, 2011
Time : 01:00 PM EST | 10:00 AM PST
Biggest challenge for Pharmaceuticals/ Biotechno...
Tuesday, 22nd February, 2011
Time : 10:00 AM | 07:00 AM
Critical aspects of applying QbD to pharmaceutic...
Friday, 6th May, 2011
Time : 02:00 PM | 11:00 AM
Biologics Battlefield: Opportunities and Obstacl...
Thursday, 30th June, 2011
Time : 02:00 PM | 11:00 AM
Vital Success/Failure Regulatory Perspectives an...
Thursday, 15th September, 2011
Time : 02:00 PM | 11:00 AM
Good Laboratory Practices (GLP) Compliance and A...
Friday, 11th November, 2011
Time : 02:00 PM | 11:00 AM
Good Clinical Practice (GCP): FDA Regulations, S...
Thursday, 26th January, 2012
Time : 02:00 PM EST | 11:00 AM PST
Orphan Drugs in Europe – How to use observatio...
Friday, 1st June, 2012
Time : 02:00 PM EST | 11:00 AM PST
Implementing the Compliant Good Laboratory Pract...
Friday, 10th August, 2012
Time : 02:00 PM EST | 11:00 AM PST
An overview of an innovative patient-centric ser...
Wednesday, 12th September, 2012
Time : 02:00 PM EST | 11:00 AM PST
An overview of Translational Medicine
Friday, 21st September, 2012
Time : 02:00 PM EST | 11:00 AM PST
Optimizing Site Selection for Global Clinical Tr...
Friday, 26th October, 2012
Time : 02:00 PM EST | 11:00 AM PST
Optimal clinical supply planning for global drug...
Friday, 16th November, 2012
Time : 02:00 PM EST | 11:00 AM PST
Patient Recruitment & Retention Management in Cl...
Monday, 10th December, 2012
Time : 02:00 PM EST | 11:00 AM PST
GMP's for Dietary Supplements: Keys to Success w...
Thursday, 30th October, 2014
Time : 01:00 PM EST | 10:00 AM PST
Is It Safe? A Cautionary Tale and Practical Guid...
Friday, 9th January, 2015
Time : 02:00 PM EST | 11:00 AM PST
How To Reconcile ICH GCP With RISK BASED Monitor...
Thursday, 19th March, 2015
Time : 11:00 AM IST | 06:30 PM BET
Orphan Drugs : Regulation and Reimbursement Cond...
Friday, 22nd July, 2016
Time : 01:00 PM EST | 10:00 AM PST
Panel Discussion on Best Practices to Clinical T...
Friday, 10th March, 2017
Time : 04:00 PM IST | 11:30 AM BST
FDA Requirements for Good Clinical Practice’s ...
Friday, 7th July, 2017
Time : 04:00 PM IST | 11:30 AM BST
Implementation of Pharmaceutical Quality system ...
Friday, 17th November, 2017
Time : 01:00 PM EST | 10:30 AM PST
FDA Guidance for ICH GCP E6 R2 Means for Sponsor...
Thursday, 27th September, 2018
Time : 04:00 PM IST | 03:30 AM PDT
Managing Human Error in Quality Systems: Human E...
Friday, 17th July, 2020
Time : 01:00 PM EST | 10:00AM PST
FDA approvals of Orphan Drugs and Rare Diseases:...
Friday, 24th July, 2020
Time : 01:00 PM EST | 10:30 AM PST
FDA approvals of Orphan Drugs and Rare Diseases:...
Friday, 26th August, 2022
Time : 01:00 PM EST | 10:00 AM PST
Good Documentation Guideline (Chapter <1029> USP...
Friday, 11th November, 2022
Time : 01:00 PM EDT | 10:00 AM PST
FDA - Investigating OOS results
Friday, 17th March, 2023
Time : 01:00 PM EDT | 10:00 AM PDT
Best Practices for FDA's Investigating Deviation...
Friday, 26th May, 2023
Time : 01:00 PM EDT | 10:00 AM PDT
Recorded Webinar
Vital Success/Failure Regulatory Perspectives and Best Clinical and Nonclinical Practices for American Pharma Companies, CROs and Academia
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 events.
- Experience of differences between EU and US requirements.
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 biologics development in an international setting.
Who should attend
This webinar will provide valuable assistance to :
- Patent Attorney / Patent Agents / Patent Consultants / IPR Professionals
- Pharmaceutical companies or financial or investment institutions, or service providers as CROs, CMOs concerned with Biologics/Biotechnology/ Biogenerics, Biopharmaceuticals/ Biotherapeutics
- Head/VP/Director, Senior Managers of Commercial Affairs, Business Development, Marketing & Sales, Commercial Affairs, Legal Affairs Pricing and Reimbursement, Health Economics, Intellectual Property, Pharmacovigilance, Clinical Immunology
- Head/VP/Director, Senior Managers of R&D Biotechnology Clinical/Nonclinical/Pharmaceutical
- VP / Director of Product Development, or QA
- VP / Director of Business Development
- Director Regulatory Affairs or Clinical Operations
- VP / Director of Pharmaceutical/Healthcare/Biotechnology
- QA Manager
- Clinical Quality Assurance
- Research and Development
- Clinical Serv
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.