HORN Pharmaceutical Consulting
Projektmanagement, Consulting, Training
Keeping information fresh and reinforcing new learning is a constant challenge for everyone. If your organisation / company wants to comply with the European, US and ICH requirements, you need well qualified experts with up-to-date information.
Active Substance Master File (ASMF)
HORN Pharmaceutical Consulting is offering state of the art, cutting edge trainings and workshops in the area of:
· Common Technical Documents (CTD)
· Good Manufacturing Practice (GMP)
· Good Laboratory Practice (GLP)
· Good Clinical Practice (GLP)
· Regulatory Affairs
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. The format of our workshops ranges from general training sessions to specifically tailored in-house solutions. All training courses will be adapted to your requirements and your target group and — if necessary — designed completely from scratch. After all, they have to be suited to your individual situation and provide your company with recognisable added value.
We will teach you the most effective strategies and issues related to regulatory strategies, clinical trials, drug development, manufacturing and testing. Our courses are designed for all scientists (managerial and laboratory) and professionals in the pharmaceutical and biotechnology industry. Whether you are new to the pharmaceutical industry or you simply need refreshing training, HORN Pharmaceutical Consulting will consider your specific needs.
Dr. Hiltrud Horn, the founder of HORN Pharmacetuical Consulting, has more than 19 years of experience in the pharmaceutical and biotechnology industry. She is regularly invited speaker at conferences, workshops and seminars on the development and registration of new chemical entities and biotechnological products.
Our Regulatory Affairs Training program covers topics through all phases of drug development, i.e. from clinical trials to submission as well as post-approval activities.
Good Manufacturing Practice (GMP)
Major emphasis of our GMP training courses is placed on understanding the need for and the intent of the various GMP-requirements in US and Europe and to develop mechanisms for implementation and compliance.
Good Laboratory Practice (GLP)
After our GLP training, all participants will have gained a fundamental understanding of the basis of the regulations, the necessity of rigorously implementing them, monitoring compliance and pro-active thinking in all scientific matters.
Good Clinical Practice (GCP)
HORN Pharmaceutical Consulting GCP trainings are designed to provide the attendee with thorough knowledge of GCP requirements and an overview of quality assurance for the conduct of clinical trials.
For more detailed description of our services please visit our website:
, advanced therapy industry
, API (Active Pharmaceutical Ingredient) manufacturer
, Biotech products
, Certificate of suitability (CEP)
, Clinical Development
, contract laboratory
, CTA (Clinical Trial Application)
, Due Diligence
, IND (Investigational New Drug Application)
, MAA (Marketing Authorisation Application)
, medical device industry
, NDA (New Drug Application)/ BLA (Biologic License Application)
, New chemical entities
, Non-clinical Development
, quality systems
, Regulatory Affairs
, Regulatory Authorities
, Regulatory Intelligence
, SME (Small and Medium-sized Enterprise)