Last month Firstline Pharma attended the MHRA Symposium in Glasgow. A great opportunity to network with industry specialists, get useful insight into changing regulations and prepare for forthcoming changes to borders and trade agreements as Brexit looms.
Attending the Symposium is always an exciting event as it brings together different sectors of the industry and gives you a chance to find out what’s new in the world of pharmaceuticals.
Who Are We?
Firstline Pharma is an established distributor of medicines and pharmaceuticals, distributing to the UK, Middle East, Africa, Asia and Europe.
How are we Regulated?
We are regulated by the MHRA (Medicines & Healthcare Products Regulatory Agency) who monitor our processes and practices to ensure that they are undertaken in a way which is safe, does not affect the integrity of the pharmaceuticals and that they are stored and distributed through properly vetted channels to ensure patient safety. As a trusted distributor, it is essential that we stay abreast of all of the latest developments and changes to international regulations.
How MHRA Communicates Changes
One of the ways in which the industry stays informed is through a conference or symposium. Last month we attended the MHRA GMDP Symposium 2018 in Glasgow. GMDP stands for General Manufacturing and Distribution Practice. GMP and GDP are separate guidelines which advise and inform manufacturers and distributors in safe manageable procedures which protect staff and patients.
The reasons we attended the Symposium were to:
- Gain greater knowledge of the quality issues affecting our organisation
- Have a clear understanding of our key responsibilities and accountabilities as Qualified Persons, Head of Production or Responsible Persons with a clear focus on the legal and compliance aspects.
- Gain detailed knowledge on the best in class standards of GDP (Good Distribution Practice) and why it is so essential for patient safety.
- Recognise commonly seen GDP deficiencies and learn how to improve compliance in our organisation.
- Be familiar with new GMP and GDP guidelines as covered by EU directives/regulations and guidelines.
- Gain a comprehensive understanding of the MHRA expectations and how to address and correct actual deficiencies.
- Have an opportunity to share concerns and learn directly from the MHRA.
- Discover what our peers are doing through managed workshops and network with like-minded professionals.
- Learn how to apply Quality Risk Management principles across our supply chain, allowing us to make best use of our resources.
- Meet the experts: attend surgery sessions with key speakers.
What does the Symposium Do?
This symposium brings together the disparate sections of the world of medicine manufacture and distribution and gives them the valuable opportunity to hear from leading experts in the field of medicinal distribution and manufacture, sharing best practice, pitfalls and observations relating to the evolving economic and social landscape worldwide.
All pharmaceutical distribution companies, including Firstline Pharma, are regulated by the MHRA. Providing top line guidance, expert advice and assistance in the safe manufacture, storage, conveyance, distribution and dispensing of medicinal products.
Because of this, the MHRA’s symposium is the primary vehicle for communicating any new and important changes to the industry.
The distribution of medicine is a diverse and complex business, standing astride many international borders and legal systems. These stretch from the laws governing the safe labelling and exporting of medicines and pharmaceuticals, the creation and maintenance of safe, temperature-controlled environs in which to transport the medicines, to the security of the medicines once they arrive at their intended destination.
Agenda for the Symposium
The agenda for the conference will address issues concerning the economic climate, in anticipation of Brexit and European trading partners. The symposium gives particular prominence to discussions relating to Leaving the EU, Brexit and the potential consequences of a more Eastern-centric wealth and power base as emerging economies in India and China continue to gain traction.
Other seminars cover subjects including: The Cost of Compliance, Data Deficiencies, The Role of Enforcement, The Supply of Active Substances, Keeping Knowledge up to Date in a Changing Business Environment and a particularly poignant talk on the Falsified Medicines Directive and how to deal with any issues encountered.
The Symposium gives great importance to creating opportunities for a feedback session and as such, has organised that the latter part of each day be set aside as a sitting surgery for industry professionals to have opportunity to quiz and canvas opinion from industry experts on any pressing matters or concerns they may have which may not have been covered during the seminars.
The MHRA GMDP Symposium 2018 was held both in London and Glasgow to give pharmaceutical firms from all over the UK the opportunity to attend.