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Recorded Webinar
Essential Regulatory Perspectives and Best Clinical and Nonclinical Practices for Indian Pharma Companies in support of EU and US MAA/NDA/BLA Regulatory Submissions
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 drugs and biologics. Important is not only the right information, but recognition that a study can be grossly undermined by poor, incomplete or inaccurate presentation of reports. Is it relevant if the nonclinical and clinical study 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:
- 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 in India is 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
This webinar will provide valuable assistance to all regulated companies, since complaint handling is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
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