Intro to the Responsible Person (import) – RPi Training
As the UK leaves the EU, the impact on the pharmaceutical industry is immense. This session is an overview of considerations to ensure compliant trading within Europe from 1 Jan 2021.
For up to date information on the current situation look here : https://www.gov.uk/guidance/acting-as-a-responsible-person-import-from-1-january-2021
Why Consider us for this session?
If you are currently working in a company who imports from any country outside the UK, from 1st January 2021, the company will need to nominate a Responsible Person for Imports (RPi).
The RPi has an important role in ensuring that only bona fide quality medicines are imported into the UK and ensuring appropriate systems are in place to control and evidence the process. To be a RPi you must have undergone suitable training and understand the industry in order to qualify for the role. RPi’s will have a legal responsibility to ensure that batches of authorised medicines imported from countries on an approved list, held by the MHRA, have been certified by a Qualified Person prior to being placed on the UK market. If you are a person named on the Qualified Persons register you be eligible to act as a RPi, however you must still apply to be named on the RPi register
The course is beneficial for personnel involved in the pharmaceutical industry, to help them to obtain a more in-depth understanding of this new RPi role, how to register for to be and the scope of the role.
Our RPi Introduction Includes
During the course we will cover, but will not be limited to the key subject areas listed below.
- Implications of Brexit
- QP Certification
- The role of the RPi
- The MHRA “White List”
- Medical Devices
- Marketing Authorisations
- Clinical Trials
Upcoming Courses
Please contact us for more details.
Testimonials
“Steve was really engaging and gave really good examples within industry and real life, Making the content relatable and understandable.” – MH, Kuehne+Nagel – Cogent RP Training – April 2024
“This is the pharma cogent course “ronseal” excellent through the whole process”
The training was delivered in a relaxed and friendly atmosphere. The elements of the training were explained in a clear and concise manner and the course was tailored around your individual requirements. The day was enjoyable and I would not hesitate to use your company again.
Tracy Tollervey from CPG – Logistic.
Very interesting presentation which allowed me to gain a proper overview of the GDP process.
Isatec on site training – Jack Shock
Pharmacy Consulting has helped manage our Company through all GDP compliance and RP training requirements, It is a pleasure to work with such a dedicated team. 10/10 –
Pharmacy Consulting have provided us with a prompt and professional service, including advice, GDP training and helping us with a robust customised Quality System.
During this time they have been committed to fully understanding our company needs and have consistently delivered excellent service.
I would highly recommend PCL to any business for peace of mind and sound professional advice.
Ben Funnell
Director
Universal PS
“The training was informative, covering all areas.”
Anonymous – Course Rating 10/10
“Very Informative and useful session”
Rahinatu – Course Rating 10/10
“A very small group (2 of us attending) but this was excellent! Very interactive course, very informative. Gained a lot of information to take away. Thank you very much.”
Jane Lytwynchuk – Course Rating 10/10
We contracted PCL provide us with help and guidance and training, relating to pharmaceutical transportation, we found Jackie and her team to be helpful, knowledgeable and pragmatic in their advice. The training sessions went well and were very useful in helping us understand the subject.
We looked long and hard for an industry expert in this field and we certainly found one in PCL.
Andrew Fox
DX (Group) plc
“A lot of valuable information to digest! Thank you.”
Anna Drys – Course rating 9/10
“Great Presentation, very informative.”
Roshni Rutton-Patel – Course Rating 10/10
“Really enjoyed the training session over the last 3 days, John was a great presenter who did really well considering he had an
audience from all over the UK…infact the world! I’m sure the face to face/classroom style presentation would have been more
interactive as I certainly missed being able to bounce off others but this is no fault of John or the course contents. Learned so
much from the past few days, more than I actually realised that I would. Thank you!” February 2021
“The training was well presented and interaction with other participants was encouraged and helpful. I attended the online course previously but this was far superior and was very helpful in giving me information and advice that I would not have received from the online course. Very enjoyable!” – RL, Health Grove Ltd, November 2024
“This one day training package cover, including Good Distribution Practice (GDP) and Responsible Person (RP) roles and responsibilities, ‘packed a punch!’ Well structured, well delivered and interactive. Good value for money. Good day out overall.”
Anonymous – Course Rating 8/10
Jackie has proved to be a very knowledgeable and professional recruitment consultant, All communications have been very professional and I would not hesitate to recommend Jackie.
Jackie is very knowledgeable, I have learnt so much from her in so little time. Thank you Jackie for being a fountain of knowledge!
” There was a lot to take in, the course was very detailed”
John Sie Han Woag – Course Rating 9/10
“Many thanks to Brain the trainer”
Wagdi Moussa – Course Rating 9/10
Very good overview of GDP requirements which has given me a much better understanding of client requirements for the services and products we supply.
Isatec on site training – Bill Castle
Our trainer Jackie was extremely knowledgeable and the way how the material was presented was very interesting. I found her also very helpful, explaining every questions and doubts perfectly. I would highly recommend Jackie as a trainer and also as a consultant.
We loved your training at Niche!
“The course was very informative and delivered by Brian in a positive way with lots of examples, to help understand the various topics.”
Kalpesh Patel – Course Rating 9/10
The course is very informative and comprehensive which covers all aspects of EU GDP guidelines.
Excellent content and delivery. After the GDP/RP training course I’m feeling informed and empowered to ensure compliance.
Very informative. Was hesitant about attending but very happy I did. Jackie was excellent.
“Very informative and very helpful. Brian was very professional and very patient with our numerous questions. Thank you.”
Catherine Hodges – Course Rating 10/10
“Lot’s of information and keeps you engaged.”
Abbey Tullett – Course Rating 10/10
“Nice Chap, explained everything in an easy to understand manner!”
Andrew Kruinlger – Course Rating 10/10
“As a nurse adviser I wasn’t sure of the relevance to my role. It was interesting and I learned a lot.”
Course Rating 6/10
“I would like to thank Brian for coming up to us – he made a difficult subject easy to understand and also helped us with real life
scenarios – not just following the curriculum, which whilst hurt our timescales – was much more beneficial for us.” Cogent (Face to Face) Training – November 2021
“Felt that the trainer was exceptional and had a thorough knowledge of the Regulations, course and Pharma industry as a whole. Would love to do the RPi course with him” – NK, Ceva Logistics – Cogent RP Training, May 2024
Very informative, Jackie created a relaxed atmosphere which was conducive to active participation of the whole group. Jackie also provided a summary of the recent MHRA convention which was very beneficial.
“A really useful day.”
Martin – Course Rating 10/10
“The trainer Wes was amazeballs. She showed deep knowledge in the subject matter and was very engaging”
“As participants, we were all able to interact, engage and shared a worth of knowledge and opinion from various industries. This made the sessions very informative, valuable and interesting.”
“Very clear, simple to follow. Interactive. Helpful.”
Ade – Rating 9/10
“Excellent course, trainer and material were superb.” – KT, Hameln Pharma Ltd – Cogent RP Training – April 2024
“I really enjoyed the course and will recommend it highly to anyone planning to apply for WDA or training to become RP. The Tutor was very knowledgeable and experienced. I learnt so much from the training so I can only thank you.”
Cogent Online Training – March 2022
“Great delivery by Brian, thought his presentation was well spoken and easy to follow, impressed with his knowledge on tricky Q&A” – GDP, October 2023
Sandeep has a great knowledge of the subject “A good course”.
Thanks.
24/04/2019 – Guy Spires from PRS distribution
I have really enjoyed the training. Zul is a very good communicator and very approachable. 🙂
Well structured and presented course. Puveshni was very knowledgeable in the field and benefited from her experience.
Abdirahamn Sheikh – Irmaan
“Excellent course and extremely practical.” Online Cogent, March 2021
A lot of valuable information to digest.
Thank you
Anna Drys – Oxford Hospital
“Well prepared and delivered presentations which were insightful, interesting and helpful to any new RP.” – January 2021
“The API training course provides a good framework foundation focused on API distribution.
I only wish I had found the API course much earlier, it would have saved me months of puzzling on some issues relating API importation and distribution. I am a novice when it comes to Medicinal product regulatory compliance. For months I have been rolling in the Green Guide but the Green Guide focuses mostly on Finished Form medicine, so I end up with just as many questions at the beginning, albeit a different set of questions. The API course finally answers my fundamental questions on API distribution, and yes I have a plenty of Q&A time with the trainer which is of great benefit to me.
I am so pleased with the API course, I immediately start working with one of their consultants on specific issues I face in my company.
.” Yu Wang, Donglun Ltd – API Training, July 2021
“Excellent trainer, very informative.”
Anonymous – Rating 10/10
“Kim was able to give good examples, in order to understand. She would also ask us specific questions and if we didn’t understand she would word it in a different way which really helped me to understand GDP.”
Suzi – Course Rating 8/10
Waisain Al-Shamary was a lovely tutor – she allowed people to contribute and she managed a couple of strong characters with
grace and patience – December 2020
“Brilliant training provided, answered all questions.”
Ashish Morar – Course Rating 10/10
“It is always difficult to provide and undertake virtual training. Wes did well getting through all the material and encouraged
interaction among the group. This was difficult but at times good discussion did open up. There were no technical difficulties in
terms of the training provision, and everything ran to time, if not a bit quicker than expected. I did enjoy it and remained engaged throughout.
There was a lot of content and to begin with I felt a little overwhelmed and anxious about the five assessments
looming at the end. However Wes reassured us that we had the info we would be needing and rather than worry about taking notes, better to listen and take in the lesson. Which worked. I gained some useful insights which I will take back to work. I go back feeling much better equipped to aid the RP with our QMS.” November 2020
Having just completed the very informative API and Clinical Trail course (thank you Shankar) I was reminded of the traps we can fall into whereby we try to keep ourselves in our little boxes. At the MHRA symposium, I have heard several times comments such as:- “no, I’m not doing the GMP day as it’s not relevant to me” or “GDP? Oh, that doesn’t apply to us as we are manufacturers”. I am sure these comments were made well out of the earshot of MHRA personnel and on the face of it seem harmless enough, though clearly wrong.
I truly believe that we should all expand our knowledge and understanding as much as possible, and certainly where there are crossovers with our speciality. For a Pharmacist or wholesaler, knowing more about GMP, APIs and Clinical Trials must be useful in our ability to fulfil our obligations in our own field. Yes, some aspects of GMP are very technical but there are big parts of it that can be used positively in the GDP arena.
As my exasperated tutors used to say during my pharmacy degree, “you will only get the most out of the topic and excel, if you read around the subject”.
I found the course on Training to be a responsible person to be a very well thought and structured course which gave me the roles and resources to come away understanding the training given. It was very informative, topical and saved me time and money trying to wade through a minefield of work to become a responsible person – Jackie is highly qualified and delivers an excellent course, would highly recommend to anyone looking at wholesaling.
“Mr. Brian Lindsay has been a down to earth trainer. His approach to the GDP and training has been excellent, and i personally have gained a wealth of knowledge that made me appreciate what GDP actually means.”
Mr Sanjay Budhdeo – Course rating 10/10
Very informative. Thank you.
“The training was well structured and everything covered was relevant and will be easily applied to our working environment. The trainers were very knowledgeable and ensured there was interaction from the group throughout. The time length of the course was perfect and this helped with keeping the group engaged. Would highly recommend this course/structure.” – VR – UHB NHS Logistics, CD Training, September 2024
“Good Training day, thank you.”
Course Rating 10/10
Good knowledge and practical insight into the requirements.
“Excellent content and delivery. Answered all questions with good detail.”
Course Rating – 10/10
Very impressed, covered the majority of topics.
James Weston – Orderline
Kim was helpful at answering all my questions and advise on how to do things independently or with the help of PCL.
“Brian is very thorough and very informative. Interactive too. A++++, Highly recommended”
Anonymous – Course Rating 9/10
I am new to GDP and the trainer was very patient with my endless questions and answered them all with rounded practical answers that i can take back to my workplace and implement.
Shirley Clifton – Ashford and St Peters Hospital
Very informative and delivered well. It was a good introduction into a subject I haven’t dealt with before.
Jackie kept the course “light & breezy”
“Training was well laid out and followed a great structure. The trainer was very very good and very attentive”
“Very interactive, answered all my questions and pointers in the right direction.”
Ade – Course Rating 9/10
“MHRA GDP guidelines are numerous and specific and potentially serious if not followed. The training went through each point in a common sense way, so the guidelines have appeared far more admirable and attainable.”
Philip Hodgkinson – Course Rating 10/10
“Wes was brilliant, encouraged us to be interactive and answered all the questions we posed. She was positive and patient. Fantastic trainer”
This session has been very informative and an eye opener. Jackie was excellent in her delivery.
“Good informative training, very helpful for the future.” GDP Online Training – May 2021
“Excellent delivery and trainer is very knowledgeable.”
Anonymous – Course Rating 10/10
Both Jackie and Sandeep made it really easy to understand the content – they encouraged discussion but also made sure that focus was given to areas specific to the attendees.
Overall I enjoyed the course and found it far less overwhelming than I expected.
“Very helpful, clear, and precise. Thank you.”
Rachel Wicks – Course Rating 10/10
” Very useful day with a good overview of MHRA GMP and GDP process, procedures and roles and responsibilities. Thank you Jackie.”
Andrew King – Course rating 9/10
“Excellent training sessions provided. I have thoroughly enjoyed and learned in all sessions. Steven presented and taught the content very well and was very knowledgeable about all topics, and supported further with any adhoc questions through the training. Thank you :)” – Cogent RP Training – April 2024
“The trainer was knowledge and answered all questions thrown at him. Training was interactive and everyone engaged. Thank you Steve for a wonderful training session.” Introduction to the RPI Role – August 2021
“I really enjoyed the 3 days training, it has made me think about my new role and how I’m going to apply this knowledge and take it forward.” – January 2021
“Excellent refresher, very informative. Thank you.”
Addy Mohammed – Course Rating 10/10
“I was a brilliant course and it opened my eyes. It gives me a platform to diversity my profile of practice.” Cogent Online Training – December 2021
Informative & Interactive. Thank you.
“Very informative course, well laid out and very educational throughout the whole course.” – Cogent RP Training, September 2024
Pharmacy Consulting have provided our business with excellent support, advice and training with regard to obtaining Wholesale Dealers Authorisation following the implementation of European Commission Guidelines of 5 November 2013 on Good Distribution Practice, 2013/C 343/01. I would like to personally thank Dawn and her team for her personal assistance in securing the authorisation.
The GPD session at PCL enabled me to focus on the really important things when it comes to getting your wholesale licence.
Dawn structured the workshop in a very lively and interactive way so it is easy to follow and to use her ideas for your own business. It was very helpful, I decided to book the Audit training too.
“The training was concise to the point and left plenty of room for questions. 1 week later and already applying it to my day to day.” – Audit Training, September 2021
“Steve is a fantastic trainer with a wealth of knowledge and the ability to be able to apply that knowledge to real life situations. Fantastic course extremely well delivered. Thank you.” – MM, Kuehne+Nagel – Cogent RP Training – April 2024
“Great course from a knowledgeable trainer. Remote webinar worked perfectly and still enabled interaction and group discussion. Trainer was also extremely helpful with advice after the course was over. Would recommend to anyone” Cogent Online Training – April 2021
Again, I stress how much I appreciate all your help, both today and through the whole journey of us striving to obtain our WDA(H).
“Really well presented and explained. Have a much better understanding of a very involved subject.”
Vicky Stones 10/10
Jackie has the experience and ability to support new and existing pharmacy businesses unlike any other.
“An ‘All-Inclusive’ Training”
Pop Ohelga – Course Rating 10/10
“Excellent – Helpful. I was in a small group setting, so very informal and easy to ask questions.”
Justin – Course Rating 9/10
“I am new to GDP and the trainer is very patient with my endless questions and has answered them all with rounded practical answers, that I can take back to my workplace and implement it.”
Shirley Clifton – Course Rating 10/10
“Very informative and lots of opportunity to ask questions and speak with other people on the course.”
Megan – Course Rating 10/10
“I found this course much more interesting and accessible than i thought it would be. Nicely paced with enough information to be challenging and thought provoking but not overwhelming. A few of the initials could do with explaining though.”
Jennifer Kirby – Course Rating 9/10
“Enjoyed the course. Informative and interesting. Presented in an engaging way that encouraged questions and dialogue. Would recommend it to others” – Cogent Responsible Person Training – February 2024
“Very informative and John was able to demonstrate a great knowledge of export. Having already completed Pharmacy Consulting’s GDP training, I was able to understand the content and what John was explaining in regard to export”
Anonymous – Rating 9/10
I attended the GDP Responsible Person Cogent “Gold Standard” training course and found it very informative, the trainer was very knowledgeable and answered all questions to a high standard, I learnt all aspects of GDP and gained knowledge that will help me greatly within my role at work and in an RP Role. 10/10
“One of the best Teams training sessions I have attended. It was clear, concise and pitched at the right level. The trainer was extremely knowledgeable, articulate and presented the subject well.” – DW, University Hospitals Birmingham, CD Training – September 2024
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