Regulatory Affairs Training

"Give a man a fish and you feed him for a day. Teach him how to fish and you feed him for a lifetime." 
                                                                                                 Chinese proverb

Dealing with the up-to date requirements of the regulatory Authorities is not an easy task. If your organization wants to comply with the European, US and ICH-requirements you need well qualified experts with up to date information.

HORN Pharmaceutical Consulting offers state of the art, cutting–edge regulatory affairs training. Our workshops will offer direct solutions for your particular problems. We share our knowledge in an enthusiastic, interactive manner.

Our training program covers topics through all phases of drug development, i.e. from clinical trials to submission as well as post-approval activities. We will present you the latest developments in the regulatory framework. Our courses focus on various types of areas in the pharmaceutical and related industries and will look at policies, procedures and experiences relevant to those areas. Furthermore, we will provide you with basic and thorough understanding for the preparation, review and approval of clinical documents, e.g. investigator’s brochure, study protocols, study reports, clinical overview, clinical summary.

In the quality area you will learn how to effectively write CMC-documents (i.e. quality part of your IMPD or CTD) considering the specifics of your novel chemical or biotech drug substance.

You will learn about regulatory strategies and how to navigate effectively your product through clinical trials and through the approval process. We will provide you with specific guidance on how to prepare for inspections triggered by national Authorities, EMA or FDA.

Services

We provide general training courses and specifically tailored in-house training in the following areas:
  • Procedures in Europe (centralized and decentralized procedures) and US
  • Strategies for product development
  • Requirements for Clinical Trial Application (CTA) and Investigational New Drugs (INDs)
  • Strategies for obtaining global marketing authorisations (MAA, NDA, BLA-submissions)
  • Meetings with regulatory Authorities (EU and US)
  • Writing and assessment of CTD-documents
    • Module 1: Application form, package insert and labelling
    • Module 2: Quality overall summary, clinical overview, clinical summary, non-clinical overview, non-clinical summary
    • Module 3: Quality (CMC) documents
    • Module 4: Non-clinical documents
    • Module 5: Clinical documents
  • Preparation of electronic submissions (e-CTDs)
  • Ensuring regulatory compliance
  • Preparation of responses to questions from Authorities
  • Post-submission activities (variations/changes and renewals)
  • Specifics of biotech products
  • Line extensions
  • Readability user testing
  • Project management and planning
  • Quality assurance
  • Quality control
  • Analytical development
  • Process development
  • Process validation
  • Analytical validation
  • Manufacturing issues
  • Stability testing programs
  • Regulatory Affairs for newcomers

HOTLINE

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

Events

  • 26.-27.02.2019
    Mannheim: GMP-gerechter Prozess-Transfer
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  • 19.-20.03.2019
    Prague: How to write the Quality Part of an IMPD
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  • 26.-27.03.2019
    Copenhagen: Handling Changes and Variations
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News

  • 10.03.2017
    News for the Industry
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  • 26.07.2013
    News on Change Control/Variations:
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  • 31.01.2013
    EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
    More
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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.
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