News
New FDA Guideline for Oligonucleotide Therapeutics
In June 2024, the FDA published the final version of the guideline titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry”. This document replaces the draft from 2022 and provides (...) Read more
New EMA Guideline on Topical Products: Impact on IVRT and IVPT
The European Medicines Agency (EMA) announced in October 2024 the adoption of the long-awaited guideline on the Quality and Equivalence of Topical Products. The final document was drafted back in 2018 and will be coming (...) Read more
miRNA Analysis: From Fundamental Research to Product Innovation
The Nobel Prize in Medicine for 2024 brings long-awaited recognition to a once-overlooked molecule: microRNA, or miRNA. This year, the prize is awarded to scientists and researchers Victor Ambros and Gary Ruvkun for the discovery (...) Read more
ICH M10 Comparison with EMA and FDA Past Guidelines on Bioanalytical Method Validation
Although the ICH has published recommendations for the validation of analytical methods used in the evaluation of the quality of drugs and active substances (ICH Q2) for more than 25 years, it was not until (...) Read more
DG-GT Meeting: Dresden, DE | 10-11 Mar 2025
BIO CHINA 2025: Suzhou, CHN | 13-15 Mar 2025
BIO-Europe Spring: Milan, IT | 25-26 Mar 2025
German Pharm-Tox Summit: Hannover, DE | 25-28 Mar 2025
German Biotech Days: Heidelberg, DE | 09-10 Apr 2025
MEET2WIN: Bourdeaux, FR | 06-07 May 2025
BIO KOREA 2025: Seoul, KR | 07-09 May 2025
BIONNALE 2025: Berlin, DE | 14-15 May 2025
Innovation for Cell and Gene Therapies (ICGT): Paris, FR | 22 May 2025
MabDesign Partnering Day: Lyon, FR | 02 Jun 2025
Congrès Polepharma Biotesting: Evreux, FR | 04-05 Jun 2025
International Oligonucleotides and Peptides Conference: Prague, CZ | 09-11 Jun 2025
AFI Simposio: Rimini, IT | 11-13 Jun 2025
Antibody Industrial Symposium (AIS): Tours, FR | 25-26 Jun 2025
CPHI 2025: Frankfurt, DE | 28-30 Oct 2025
