Are you ready for May 2021 and the new Medical Device Regulations?
The European Union’s Medical Device Regulation was delayed earlier in the year when the EU Commission, Council, and Parliament delayed the regulation’s application to May 2021…
LOGISTICS TECHNICAL AGREEMENTS
Many transport services in the distribution and supply of medicinal products are carried out by external logistics service providers, and many other activities in the GDP environment are often outsourced also. In this context, the question arises on when is it necessary to sign a Technical/Quality Agreement? Which regulatory requirements apply? and which aspects should be covered in such an agreement?..
Temporary Regulatory Flexibilities
In its Inspectorate Blog the MHRA published a post on temporary changes in Good Distribution Practice (GDP) entitled “How to manage temporary GDP process changes and risks through the COVID-19 pandemic”…
China Vs Counterfeiting
With a number of reports from over the pond of Mr Trump praising China, even in areas where I think most sane people will think ‘there is room for improvement’, I am a little reluctant to join in but credit where it is due…
Buy British, will the public shun Chinese products?
As the pandemic still rages in many countries and bruised countries like the UK take their first steps to kick start the economy will we return to our normal reliance on the global supply chains?
Active Substance and Clinical Trials course
Early bird fees for our new Active Substance Course and Clinical Trials course being run next Tuesday- 23rd June, 20th of July and 11th of August will be applied to bookings made within a week of the course.
API and Clinical Trails Training
Shankar Seetharaman is a Qualified Person with many years of experience in API auditing and clinical trials supply. He currently is the Managing Director of Pharmanswers Ltd which is a consultancy with a proven track record of providing quality and regulatory support for the pharmaceutical industry…
UK trade agreement
More trade is essential if the UK is to overcome the unprecedented economic challenge posed by the Coronavirus. The UK’s priority is to launch negotiations with the EU, the US, Australia, New Zealand and Japan…
Border controls and procedures after the Transition period.
UK government will not be extending the transition period, which means The transition period will, therefore, end on 31 December 2020, in line with the provisions of the Withdrawal Agreement. New rules will take effect on 1 January 2021…
Lockdown coming to an end?
We are all looking forward to having our lives back to normal. But will it be normal again?