GCP Training

Due to the constantly changing regulations, being in compliance with the Good Clinical Practices (GCP) standards is a highly challenging task for the pharmaceutical industry. Pharmaceutical and biotechnology companies are increasingly using trainings to increase the competency of their employees. At HORN Pharmaceutical Consulting we recognize the significance and importance of training and education for all clinical research personnel. Our GCP training courses provide a solid understanding of GCP requirements and an overview of quality assurance for the conduct of clinical trials.

No matter whether you need basic or expanded knowledge in regulations for GCPs, our specialists will provide you with the training needed to improve clinical trials and ensure compliance with Good Clinical Practice. Our goal is to provide your employees with an in-depth understanding of the clinical research process, the roles and responsibilities of key players, as well as, regulatory requirements.

In-house Training

The ability to have your specific concerns addressed and discussed is one of the most important factors in any educational program. We offer particularly tailored in-house trainings. Guided by the principle “learning by doing”, we give you the opportunity to exercise what you have learned. In specific workshops, the training participants will be placed in several real life situations such as reviewing pre-study documents and informed consent forms for completeness and compliance; conducting drug accountability; reviewing case report forms for accuracy and adherence to protocol and performing source document verification.

Services

Our specifically tailored GCP-trainings are designed to provide the attendee with thorough knowledge of the following topics:
  • How drugs are discovered and developed for marketing approval
  • What constitutes Good Clinical Practices (GCP)
  • Clinical drug development: trial design and phases
  • The principles of ICH GCP
  • The purpose of a CTA/IMPD as well as IND and its composition
  • How Clinical Trials Applications (CTAs) and Investigational New Drugs (INDs) are filed, reviewed, approved & amended
  • The CTA and IND reporting requirements
  • Specifics for Europe (EU Clinical Trials Directive) and US
  • GCP requirements for Investigational Medicinal Products (IMPD)
  • The different types of study monitoring visits and tasks for each
  • The purpose and composition of the NDA
  • How marketing Authorisations (MAAs) and New Drug Applications (NDAs) are filed, reviewed and approved
  • Sponsor responsibilities after approval
  • How to review study documents and determine compliance
  • How to review case report forms and determine adherence to protocol
  • How to perform source document verification
  • Development of Standard Operating Procedures
  • Quality Assurance audits for clinical trials
  • Quality issues and audit findings in clinical trials
  • How to prepare for authority inspection of clinical trials (FDA, EMA etc.)

    HOTLINE

    Phone +49 (0) 7251/305 529
    Fax +49 (0) 7251/305 528
    Mail

    Events

    • 29.08.2019
      Frankfurt: Prozessvalidierung - Aktuelle Anforderungen für CMC
      More
    • 17.-18.09.2019
      Copenhagen: Drug Master File Procedures in the EU, the US and Japan
      More
    • 27.09.2019
      Frankfurt: Regulatorische Anforderungen an Primärpackmittel
      More
    Get all events



    News

    • 10.03.2017
      News for the Industry
      More
    • 26.07.2013
      News on Change Control/Variations:
      More
    • 31.01.2013
      EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
      More
    Get all news
    EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?
    EU: Centralised Marketing Authorisation Procedure for ATMPs needed Have you already filed your application? The time clock is ticking. Transitional periods will be over soon.
    This website uses cookies. By using the website you agree to the use of cookies. Privacy Policy X