Webinar Recording
US NDA versus EU MAA eCTDs
Exploiting the Synergies and Mastering the Differences
| On-Demand | 1 Hour | Your Desk! |
Exploiting the Synergies and Mastering the Differences
| On-Demand | 1 Hour | Your Desk! |
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Adair TurnerPrinciple, Consultant, Director RegOps, PharmaLex |
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Parul PatelSenior Product Consultant, LORENZ Life Sciences Group |
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Karl-Heinz LoebelDirector, Principal Consultant RegOps Industry/Agency Liaisons, PharmaLex |
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Akira YamaguchiCTO, LORENZ Life Sciences Group |
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Melissa RappManager, RegOps, PharmaLex |
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Jan WermuschProduct Manager, LORENZ Life Sciences Group |
Initial authorization applications for new drugs and biologics in the US and Europe are among the most challenging tasks faced by Regulatory Operations. The applications typically include approximately 1,000 documents and hundreds of thousands of pages that need to be authored, reviewed, and published (usually under very tight timelines). While the harmonization brought to us with the eCTD format has certainly increased the efficiency of preparing multiple regional dossiers at once, differences in the required content and format between health authorities persists.
If you intend to cover both markets, simultaneously or sequentially, efficient submission planning and preparation is crucial. Detailed knowledge regarding the content and format requirements of each Health Authority is necessary to determine whether documents can be re-used in multiple dossiers. In addition, thoroughly understanding how your eCTD tool can utilized to achieve synergies can save you valuable time.