Crossword: Clinical Research.

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Across
  1. 2. In 2014 alone, FDA approved new molecular entities and biological products.
  2. 7. A database that includes information on clinical trials taking place in the European Union and clinical studies conducted worldwide in accordance with a paediatric investigation plan.
  3. 8. Regulatory body of Japan.
  4. 12. Health Canada is a part of which portfolio:
  5. 14. ensures that safe and effective drugs are available to improve the health of the people in the United States.
  6. 15. The Scheme in TGA which provides a simple means for practitioners and patients to identify certain types of new prescription medicines and to encourage the reporting of adverse events associated with their use.
  7. 16. The project launched by PMDA on the use of electronic medical records, etc. for safety measures.
  8. 18. CSRs should be submitted per Appendix Il of ________and International Conference on Harmonisation-Common Technical Document.
Down
  1. 1. Clinical Trial Exemption (CTX) schemes in Australia scientific and ethical review is provided by a _______
  2. 3. New Chief Executive of PMDA.
  3. 4. Withdrawal Agreement and Political Declaration on the future relationship between the UK and the EU as endorsed by leaders at a special meeting of the European Council on 25 November 2018. Name the deal.
  4. 5. The Drugs Controller General of India is advised by ____and DCC.
  5. 6. Australian Regulatory body-
  6. 9. Central Drugs Standard Control Organization functions under____, which is part of the Ministry of Health and Family Welfare.
  7. 10. Using ________, one can report a suspected problem (‘adverse incident’) with a medicine or medical device in the UK.
  8. 11. First stem-cell medicine recommended for approval by EMA.
  9. 13. Which is the body which provides information to assist stakeholders’ understanding of their regulatory requirements in Canada?
  10. 14. Which policy applies to Health Canada compliance and enforcement activities conducted in relation to health products that fall under the Food and Drugs Act?
  11. 17. Clinical trial submissions can be made through______ the UK.
  12. 19. FDA is an agency within the
  13. 20. The mission of the____ is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union.