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News: Europe

PDA: New Publications and Formation of the D/A/CH Chapter

During the press conference of the PDA/FDA Joint Regulatory Conference 2024, PDA (Parenteral Drug Association) announced interesting new publications and the formation of the new D/A/CH Chapter to support local members.

New publications include:

  • Updated Technical Report 68 “Risk-Based Approach for Prevention and Management of Drug Shortages“
    Based on the impact this issue has to the pharmaceutical companies and the patients they supply, PDA provides this updated report free of charge globally.
  • In October the book “Global Sterile Manufacturing – Regulatory Guidance Comparison & Assessment Tools“ will be published.
    The book compares guidances from the FDA, EU, WHO, PIC/S, Canada, China and Japan. It simplyfies the challenging task of looking across regulatory guidances to ensure global compliance. It comes with explanations and Excel® files to work with.

PDA formed the new D/A/CH Chapter. The chapter region consists of Germany, Austria and German-speaking Switzerland. The chapter is led by Richard Denk of SKAN AG, Switzerland.


Source:

PDA Press Conference, 9 September 2024, Washington, DC

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