Horst Kastrup

Senior Regulatory Advisor
MEDA Pharma
Horst Kastrup has a background of more than 35 years in regulatory affairs, pharmacovigilance, and quality assurance. He started his industry career at Wyeth in Germany in 1982, and was promoted to Head of Global Regulatory Affairs in 1990. In 1998, he took over responsibility as Head of Regulatory Affairs and Pharmacovigilance at ASTA Medica in Frankfurt, whose Viatris branch was acquired in 2005 by the Swedish Meda group. In 2005, corporate quality assurance was added to his responsibilities. Since 2010, he is Senior Regulatory Advisor at Meda Group. Both at Wyeth and ASTA/ Viatris/ Meda, the labelling/ artwork department was part of the Regulatory Affairs organisation and reported to him. Additionally, Horst Kastrup is a lecturer at the University of Bonn for the Master of Drug Regulatory Affairs (MDRA) course.

12:20 PM Anti-Counterfeiting Requirements with a Focus on Non-EU Areas

  • Penetrate emerging regions with confidence that you understand their unique regulatory requirements
  • Gain confidence that your products are secure from illegal counterfeiting no matter where they are in the world
  • Develop strategies to help avoid the risk of counterfeiting with clever packaging, labelling & artwork strategies

2:30 PM Airtight EU Regulatory Compliance – Ensuing your Packaging, Labelling and Artwork Strategies are 100% Regulatory Compliant and Inspection Ready

Maintaining 100% regulatory compliance is no easy feat! Knowing the regulations isn’t enough – you need to know how to interpret them, and develop strategies to practically implement them. Moreover, there is increasing pressure on packaging, labelling & artwork professionals to save costs across the entire product life-cycle. Put this all together and meeting regulatory expectations has never been harder.
Attend this workshop to:
  • Overcome the practical challenges of implementing the Falsified Medicines Directive in a cost-effective way
  • Better understand the ISO - standards (IDMP) on pharmaceutical labelling
  • Figure out what best-practice looks like when it comes to tamper evidence packaging features inline with ISO 21296
  • Understand current Good Manufacturing Practice (cGMP) guidelines and principles to avoid any safety issues
  • Decipher the complexities of the global regulatory landscape – know the local differences