RP Training/Advice
PLS Pharma are the largest provider of Responsible Person (RPs & DRP’s) Training in Ireland & the UK (2008-2019) having commenced RP Training in 2006 with the support of the Irish Medicines Board, now known as Healthcare Products Regulatory Authority (HPRA), and ran the early courses in the UK under RSSL with the participation initially of MHRA regulatory Inspectors.
PLS Pharma are the Summit founders of the RP Forum®, the 1st event was run in Europe in Ireland, Dublin in 2016. An RP is a Responsible Person (RP) who has been approved by a local country regulatory authority on a case-by-case basis and is named and approved to act as the person responsible for the WDA Licence, meeting the EU GDP Guidelines 2013/C 3430/01 and local regulatory requirements in the country where the WDA/Licence is authorised to operate. The Second and third RP Forum® took place in 2018 & 2019. The Irish Regulatory Authority (HPRA) fully supported this unique and premier compliance initiative by PLS Pharma. The HPRA present, support and have sent inspectors to speak at all the face to face Irish RP Forum® events to date.
PLS Pharma, in partnership with MHRA, and the Pharmaceutical Quality Group (PQG) which is the Chartered Quality Institute’s longest established special interest group, and has been supporting quality professionals in the pharma arena for years. We asked them to help be the go-to source for RPs in the UK.
Following meetings and discussions with the MHRA (UK Regulator) over a number of years The 1st Pilot RP Forum® in the UK ran in April 2021 in partnership with the MHRA (UK Regulator), PQG and PLS Pharma. Speakers included the Vice Chair of PQG, Neil Wayman, Tony Orme, the GDP Expert from the MHRA and Ciarán Brady, the CEO of PLS Pharma .
This event was attended by over 40 Responsible Persons who are named on UK Licences and who voted 100% to approve PLS Pharma to run the 1st formal RP Forum in UK in partnership with PQG and the MHRA. The 1st formal RP Forum ran in the UK on 12th October 2021 and Tony Orme from the MHRA answered all questions. It was a great success. The next RP Forum is planned to run in 2022.
Please check the PQG website for details.