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    The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations

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    Website https://www.demystifiedsolutions.com/trainingDetails/The-Investigational-Medicinal-Product-Dossier-I | Want to Edit it Edit Freely

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    Deadline: July 26, 2017 | Date: July 26, 2017

    Venue/Country: Online

    Updated: 2017-03-10 17:42:02 (GMT+9)

    Call For Papers - CFP

    This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out effective clinical studies in the U.S. and EU.

    Why Should You Attend

    All sponsors, CROs, Sites and auditors of Clinical Research who are involved in pharmaceutical or biological development need to possess the knowledge and be efficient in completing successful applications for their studies. Knowing what is expected of you and “getting-it-right” the first time, will allow faster development of innovative products. This translates to company and personal success and for new therapies to continue to be available to patient populations worldwide.

    Areas Covered in this Webinar

    US FDA and EU Agency Orientation / Structure

    Start –Up and Conducting Clinical Trial Processes

    Following Product Registration / Licensing Options

    Company Strategy- Linking Clinical Trials & Marketing Authorization Applications

    Balancing Strategy and Long Term Regulatory Cost & Maintenance

    IMP Dossier & Comparisons of the US IND to the EU CTA Content

    Scientific Advice: Member States vs. Pre-IND Meetings with U.S. FDA

    Orphan Drugs: EU vs. US Treatment

    GCP Compliance Inspections

    Essentially Similar and Generic Products

    Cross-Agency Interactions: Comparing U.S. FDA and EMA

    Effective Interactions with the Global Regulatory Healthcare Authorities

    Helpful Websites

    Who Will Benefit

    This Webinar will provide invaluable assistance to all personnel inthe Pharmaceutical, Biotechnology and CRO industry conducting Clinical Trials including:

    - Sponsor Senior management

    - Project Managers

    - Clinical Trial Heads

    - Medical writers

    - Project Managers

    - CRAs and CRCs

    - QA / Compliance personnel

    - Investigators

    - Clinical Research Scientists

    - QA / QC Auditors and Staff

    - Consultants

    For More Info, Please Click below URL:

    https://www.demystifiedsolutions.com/trainingDetails/The-Investigational-Medicinal-Product-Dossier-IMPD-EU-CTA-vs-FDA-IND-Comparing-the-Content-and-Agency-Expectations-DEMY051460

    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.