Clinical Trial Supply regulations, how can you ensure compliance?
With many regulations being updated or introduced to the clinical supply environment, the importance of staying up to date with these regulations and methods to ensure compliance has become crucial to success in the industry. Thus it is essential to limit these potential barriers in order to maintain an effective clinical supply chain.
Recently, the update of annex 16 has altered responsibilities of QPs in clinical trials, with a focus on approving and releasing batches. However, this modification is likely to increase the QP’s workload, and as a result, how will this affect clinical supply in your business? We will be identifying new strategies which could be deployed; to ensure your vendors and clinical teams are complying with the new regulation, as well as ways to gain GDP/GMP certification and improve efficiency across your clinical supply chain as a whole.
At the time when the new guidelines were introduced, many sponsor companies didn’t release the impact it had to their clinical supply chain. Nonetheless, the tables have turned and may affect medications which are issued to storage facilities within the European Union. Thus it is important for clinical supply companies to review its impact on the smooth running of the supply chain; in addition to the significance of regular communication with compliance manages to ensure GDP compliance.
The regulations outlined above can have a dramatic impact towards your clinical supply chain, incurring extra costs, affecting timeliness and efficiency. Join us at the Clinical Trial Supply Nordics Conference this June to examine all the improvements which could be made to ensure your business is complying with these regulations.
This is an unmissable opportunity to hear exclusive case studies and discuss pressing topics with industry professionals to ensure you are at the forefront of clinical supply! See you in June! For more information, please visit: http://www.arena-international.com/ctsnordics or email us at: firstname.lastname@example.org.
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