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1. Using RWD in Non-Interventional Studies: EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.

2. Latest EU guidelines dissected.

3. Curbing Drug Shortages in Europe.

4. European Medicines Agency Viewpoint.

5. EMA Guidance on Paediatric Investigation Plans: Stepwise paediatric investigation plans aim to boost the development of medicines for children.

6. A Question of Quality: Greater transparency and reliability of information are needed in the quality assessments of biosimilars.

7. Setting Goals for Sustainability: In light of increasingly stringent sustainability requirements, bio/pharma companies need to make sure they formulate effective ESG strategies.

8. Should Regulation of Combination Products Become More Centralised in Europe?

9. Taking on the regulators: is it worth it?

10. eCTD now mandatory for the Centralized Procedure.

11. European Regulators Struggle with Globalisation of Clinical Trials.

12. Regulation of Medical Devices and Companion Diagnostics.

13. Data Integrity Expectations of EU GMP Inspectors: The author reviews key technological expectations of EU GMP inspectors on the integrity of e-records.

14. EMA Guideline on Setting Health-Based Exposure.

15. A Risk-Based Approach to Data Integrity.

16. Generic Industry Criticises Potential European Fees.

17. Playing the Waiting Game with GMP Guideline Revisions: Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.

18. Spotlight on Assessing the Environmental Impact of Medicines.

19. A Year of Possible Regulatory Upheaval and Paralysis: This coming year could see a combination of regulatory uncertainty and inactivity for the pharma industry, mainly as a result of Brexit.

20. Guidelines on Integral Drug-Device Combinations.

21. News bites.

22. Europe Leads the Way in Continuous Manufacturing.

23. EU on a Mission to Boost R&D.

24. Labelling of Biosimilars.

25. EU Steps Up Inspection Efforts.

26. Regulation of Biosimilars: A Matter of Variability, Similarity and Comparability.

27. Advancing QbD in the EU.

28. EMA Focuses on Greater International Collaboration.

29. Are cleanroom regulations realistic?

30. News bites.