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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.


Apply for this webinar

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
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