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  • Clinical Data Management Seminar 2018

    Clinical Data Management Seminar 2018

    Clinical New Orleans (lousiana) July 5, 2018 1295.00 Dollar US$

    When new drugs or devices are tested in humans, the data generated by, and related to, these trials is known as clinical data. This data represents a huge investment by the biopharmaceutical or device company and is one of its greatest assets. It is ...

  • Verification vs Validation-Product, Equipment and QMS Software

    Verification vs Validation-Product, Equipment and QMS Software

    Drug Development Fremont (California) June 15, 2018 290.00 Dollar US$

    Overview: You will learn What do the U.S. FDA and EU Expect for Verification and Validation, Actions and documentation to meet U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements, ISO 14971 and IEC 62366 considerations, as approp...

  • Label Promotion of Drugs and Medical Devices 2018

    Label Promotion of Drugs and Medical Devices 2018

    Training and Teaching Fremont (California) April 19, 2018 Free

    Overview: This session sets the context for the off-label promotion of medical products starting with early history and moving to the most recent history of FDA's decision on guidance documents. Why should you Attend: This session will discuss commen...

  • Expectations for Products Used in Early Phase

    Expectations for Products Used in Early Phase

    Drug Development Fremont (California) March 21, 2018 150.00 Dollar US$

    Overview: This presentation will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. Areas Covered in the Session: Discussion of the elements found in the guida...

  • Fundamentals of Risk Management in Clinical Research 2018

    Fundamentals of Risk Management in Clinical Research 2018

    Quality Control, Safety & Security Fremont (California) March 21, 2018 150.00 Dollar US$

    Overview: The premise behind RBQM is that monitoring quality can be improved by leveraging existing data intelligence. This, in turn, calls for more robust quality assurance (QA) systems focused and efficient resource utilization and allocation at th...

  • GMP Regulations and How it Apply to Analytical Laboratories

    GMP Regulations and How it Apply to Analytical Laboratories

    Clinical Fremont (California) March 21, 2018 150.00 Dollar US$

    Overview: Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is be...

  • Drug Master Files and Quality Agreement Training Seminar 2018

    Drug Master Files and Quality Agreement Training Seminar 2018

    Drug Development Philadelphia (PA,PA) March 6, 2018 1495.00 Dollar US$

    Overview: This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together. Over time, there have been several misunderstandings be...

  • Label Promotion of Drugs and Medical Devices

    Label Promotion of Drugs and Medical Devices

    Training and Teaching Fremont (California) February 22, 2018 290.00 Dollar US$

    Overview: This session sets the context for the off-label promotion of medical products starting with early history and moving to the most recent history of FDA's decision on guidance documents. Why should you Attend: This class presents the latest F...

  • GMP for Phase I Investigational Drug Products 2018

    GMP for Phase I Investigational Drug Products 2018

    Training and Teaching Fremont (California) January 24, 2018 150.00 Dollar US$

    Overview: Phase I clinical trials are the first time that investigational new drugs are introduced into human subjects and, although it is very, very important for all drugs to be manufactured using GMPs, it is probably more important than at any oth...

  • FDA Guidelines for Pharmaceutical Industry | FDA Regulatory 2018

    FDA Guidelines for Pharmaceutical Industry | FDA Regulatory 2018

    Training and Teaching Chicago, IL ( Chicago, IL) January 19, 2018 1295.00 Dollar US$

    Course "FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2017 in Review" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The FDA i...

  • Drug Products for Clinical Trials | FDA Approved Drugs List 2018

    Drug Products for Clinical Trials | FDA Approved Drugs List 2018

    Training and Teaching Boston, MA (Boston) January 19, 2018 1295.00 Dollar US$

    Course "Different requirements for Phase I Investigational Drug Products: which GMPs apply since most Phase I drugs are exempt from full GMP requirements and what IND data requirements are necessary as a result?" has been pre-approved by RAPS as elig...

  • Anti-TPBG (clone A1)-AcBut-calicheamicin ADC

    Anti-TPBG (clone A1)-AcBut-calicheamicin ADC

    Drug Development Shirley (New York) January 18, 2018 1.00 Dollar US$

    https://www.creative-biolabs.com/adc/target-tpbg-100.htm This ADC product is comprised of an anti-TPBG monoclonal antibody (clone A1) conjugated via an AcBut linker to calicheamicin. The calicheamicin is targeted to TPBG-positive cancers by immunerec...