Responsible Person (RP)
The MHRA and the European GDP Guideline of 5 November 2013 require that, in order to gain and retain a Wholesale Dealer’s Licence (WDA) licence, wholesale pharmaceutical distributors must designate a Responsible Person (RP) for Good Distribution of Medicinal (GDP) who must be named on the licence. The responsibilities and liabilities of the RP remain the same whether the Responsible person is employed directly by the licence holder or is an independent contractor.
According to the MHRA, the RP is responsible for “safeguarding product users against potential hazards arising from poor distribution practices”. The duties and responsibilities of a RP includeensuring that the provisions of the licence are fulfilled by means of GDP and GMP compliance and best practice within all regulated activities, a compliant quality system is established and maintained and a suitable document control system is in place to ensure that adequate records are maintained. In addition, the RP will need to oversee the audit of the quality system, carry out independent audits and cooperate with the product licence holder and regulatory authorities with regard to drug returns and product recalls.
In order to carry out his/her duties, the RP should have knowledge of the products being traded under the licence and the conditions necessary for their safe storage and distribution. The RP should have access to all areas and records which relate to the licensable activities and regularly review and monitor all such areas.
Skills and Experience required to become a Responsible Person
- Degree in pharmacy (preferable) or Qualified Person status
- Practical experience in Supply Chain, Production and Quality Assurance relating to the distribution of medicinal products
- Extensive knowledge of GDP and GMP
- Experience of hosting MHRA inspections, client audits and self-inspections
- High level of accuracy
In addition to being the capital city of the United Kingdom, London (aka Greater London) is one of the nine official regions of England and consists of 32 boroughs plus the City of London. London is a global city with a population of 9 million and is the most densely populated region in Europe.
London is one of the centres in Europe for cell therapy, gene therapy and advanced therapies (ATMPs). Next to Stevenage, Cambridge and Oxford, London is a major site for biotechnology innovation, pharmaceutical development and rare diseases. London is the world's leading financial centre for international business and as such the financial services industry in London, including banking, insurance, broking and fund management make the largest contribution to London's economy. Other major industries in the London region include real estate, legal, accountancy, creative industries such as fashion, design and art, media and TV, legal, construction, London tourism, pharmaceuticals, biotech and retail. In recent years many technology companies, especially those in FinTech, have set up in the area of East London known as the “Silicon Roundabout”, putting London on the map as a key area of growth.#
The vibrancy of the London life sciences cluster is reflected in the activities of various networking groups which provide regular opportunities to make new contacts via events, conferences and other meetings:
One Nucleus: Established in 1997, a not-for-profit Life Sciences & Healthcare membership organisation centred on the Greater London-Cambridge-East of England corridor. Through providing local, UK-wide and international connectivity, One Nucleus seeks to enable its members to maximise their performance.
The Royal Veterinary College (RVC): The RVC is pre-eminent among veterinary schools, and offers the highest quality in undergraduate and postgraduate teaching and research - meeting the growing demand for veterinary professionals and biomedical scientists. It also provides support for the veterinary profession through its three referral hospitals, diagnostic services and CPD courses.
MedCity: MedCity represents the life sciences cluster of London and the Greater South East of England. Their expert knowledge, industry experience and sector-wide perspective means they can maximise opportunities for growth and collaboration within the region and beyond.
The BioIndustry Association: The BioIndustry Association (BIA) is the trade association for innovative enterprises in the UK's bioscience sector. Its mission is to encourage and promote a thriving, financially sound sector of the UK economy, built upon developments across the biosciences.
London has a wealth of iconic and world famous London attractions such as Buckingham Palace, St Paul’s Cathedral, the Tower of London, Tower Bridge, beautiful parks, numerous world class museums, a vibrant London theatre land and global cuisine, the combination of which attracted over 19 million visitors to London in 2016. London tourism numbers have received a substantial boost thanks to the hugely successful Olympic Games held in London in 2012.
London is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in London, scientific careers in London or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities inLondon, give our Next Phase team a call. The London area is continuing to expand as a centre for jobs in science, process development, technology, software development, project management, informatics, quality, reg affairs and supply chain.
At Next Phase we help people find new jobs in life sciences across the UK, Europe and USA. This page lists some of the job opportunities in London, and if you give us a call we can also talk to you about other scientific jobs, pharmaceutical career opportunities and the latest updates in cell and gene therapy and ATMP development in the London area.