We can create a training programme on any topic, delivered in any format. Below are a few examples of solutions we have developed for our customers. We appreciate that every customer and their situation is unique. As a result, we design and deliver programmes that factor in your specific requirements to ensure your learning and business objectives are met.
Medical Device Customer Case Studies
Case Study 1 | Medical Device Regulatory Affairs Training for a Pharmaceutical Consultancy
Scenario
There are a growing number of drug device combination products entering the market. Accelerated by advances in biotech and cell & gene therapies. Often a device is required to deliver the therapeutic medicinal product. This was the case for an Educo customer, a regulatory affairs consultancy business. Several of their clients had combination products in their portfolio using devices such as inhalers. They felt there was a gap in their knowledge when it came to the latest device requirements.
Training Need
The Educo customer required a high-level overview of the medical device roadmap to bring a device to market. This included topics such as risk management, design process, useability. They also wanted the latest MDR requirements, CE marking and UKCA marking. The team were also all working from home and the training needed to bring them together easily and cost effectively. In addition, they wanted a solution that could be used for their team as it continued to grow throughout the year.
Educo Life Sciences Solution
Educo created a live online training programme delivered as bitesize sessions. The equivalent of 2-days of training was delivered over four half days. Being online the whole team could join from anywhere in the country. The bitesize element meant it caused minimal impact on day-to-day work. The course provided a high-level overview of medical device regulations and included a workshop activity which got the team working together. All the sessions were recorded and uploaded to the Educo Training Portal, where on-demand course was built. The course remains available to the team and new employees are enrolled regularly.
Outcome
The Educo solution helped the customer understand the latest medical device requirements in the EU and UK. The team are also able to use the recordings as reference material as and when needed. This is very beneficial as a consultancy business working with varied clients. Although virtual, it also helped the team grow and develop together.
ATMP | Cell and Gene Therapy Customer Case Studies
Case Study 1 | Cell and Gene Therapy On-Demand Micro Learning
Scenario
Recently the life sciences industry has seen many developments within Cell & Gene therapies (CGT). With increasing success, the industry is receiving significant investment. In line with this an Educo client, a leading international life science company, had made several acquisitions within the advanced therapy space. Alongside incorporating these new businesses, the organisation also wanted to further invest and dedicate employee resources to focus on growing the Cell and Gene field.
Training Need
The client wanted to ensure they were best placed to efficiently distribute personnel resources onto new projects within CGT to ensure effective management and improve their chances of success. They were bringing onboard many new employees from outside the organisation and internally; all of which had a different understanding of CGT/ ATMPs. For this reason, it was crucial that they had a training that ensured a common understanding of ATMPs, the basics, an overview of their regulatory and quality challenges and the clients internal processes and interpretations.
Educo Life Sciences Solution
Educo created an online, on-demand micro learning course incorporating the client’s internal processes, jargon and interpretations. Held on Educo’s LMS the training material was made of short videos, reading materials, quizzes and games to ensure an engaging approach. Individuals were given a unique log in and able to access the material at any time and location with internet. The course recorded progress so individuals could dip in and out of the training around their busy schedules. Reports of completion and activity were provided by Educo to the client’s stakeholders so they could ensure the progression of the group.
Outcome
The Educo solution enabled the client to ensure a standardised basis of knowledge for all new employees joining CGT projects so that individuals came up to speed in a fast and effective manner, enabling them to immediately contribute to projects. The format of the training also ensured an easy administration for the client and minimal impact on day-to-day roles.
Case Study 2 | Navigating the Regulations for a Gene Therapy Product
Scenario
An Educo client, a biotech start-up, had raised a significant amount of funding to support the advancement of their innovative delivery mechanism for their gene therapy therapeutics. Their pipeline contained therapeutics for the treatment of rare and severe diseases.
Training Need
The Educo client’s need for training was threefold. Firstly, their modality is a very novel so there are currently no industry examples which their technical and R&D teams could use as a framework. Secondly, there was a lack of CTD writing experience within the different teams, so they needed to improve their understanding of EMA and FDA requirements. Thirdly, the regulations for their novel modality-based therapeutic is a grey area. It was either classified as a cell & gene therapy or biologic. The client wanted their R&D teams to receive a recurring training course focused on early development.
Educo Life Sciences Solution
Educo Life Sciences created a comprehensive and customised on-site training workshop built around the client’s objectives, processes and modalities, delivered on-site at client’s premises. For the workshop the analytical and process teams worked together to conduct two joint mock exercises to assess and design process change comparability studies and method tech transfers.
Outcome
The Educo solution enabled the client to ensure an aligned level of knowledge across their analytical and process teams for early development, becoming well-versed in Regulatory requirements and interpreting guidance documents, and successfully contributing to the advancement of the client’s novel modality-based therapeutics pipeline.
Pharmaceutical Regulatory Affairs Customer Case Studies
Case study 1 | Upskilling the Regulatory Change Management Team
Scenario
A regulatory change management team at an innovative biopharmaceutical company had several new team members join them with less experience. The team served as liaison between site subject matter experts and regulatory affairs. The team wanted to improve their understanding of the quality module of the Common Technical Document (CTD) to help in their liaison role.
Training Need
The team contained a variety of experience levels and wanted to build their knowledge of the CTD so they had the confidence to support subject matter experts and regulatory affairs. The team were located globally with most members based at their head office in the US. They also had colleagues located in Europe and other countries.
The main aims of the training course were: Firstly, create a deep understanding of the CTD and how it is maintained throughout the lifecycle of a product. Secondly, have a greater understanding of the teams they were communicating with (regulatory and subject matter experts). Thirdly, create an aligned level of knowledge of Module 3 of the CTD amongst the team.
Educo Life Sciences Solution
Due to the size of the attendees and location, a live online programme was delivered. The programme consisted of a webinar series of bitesize sessions which became progressively more advanced building on prior knowledge. All sessions were recorded and uploaded the Educo portal. All attendees were given accounts and had unlimited access to the courses for a period.
Outcome
The Educo solution provided the regulatory change management team with an in-depth understanding of the Module 3 content applicable to their different product types such as small molecules, biosimilars and mRNA. The solution also enabled the team to identify and implement change control for legacy products that required improvement.
Case Study 2 | Supporting the Regulatory Lifecycle Management of a New Product Portfolio
Scenario
A successful generics company had added to their portfolio of products through acquisition. The regulatory team responsible for lifecycle management of global products were in the process of integrating the new product portfolio.
Training Need
Although the regulatory team were experienced, the acquired portfolio contained products that the team were unfamiliar with. As they were responsible for the regulatory management of this new portfolio, the team wanted to upskill and improve their knowledge in these new therapeutic product areas.
The main objectives of the training were: Firstly, provide an overview of the new product portfolio, understanding the key regulatory considerations. Secondly, ascertain how these challenges are different from their current processes and evaluate how the new portfolio will impact them. Finally, they wanted to learn how best to plan and prepare for their integration to ensure a smooth transition.
Educo Life Sciences Solution
Educo created a case study led training programme. Using current market examples, the Educo trainer highlighted key regulatory considerations. The trainer then used an open workshop to facilitate the team in developing their regulatory strategy for the new product profiles.
Outcome
The Educo solution enabled the client to best prepare their team for the the new portfolio as well has have a clear regulatory strategy for them moving forward.
Biotech Customer Case Studies
Case Study 1 | Cell and Gene Therapy On-Demand Micro Learning
Scenario
Recently the life sciences industry has seen many developments within Cell & Gene therapies (CGT). With increasing success, the industry is receiving significant investment. In line with this an Educo client, a leading international life science company, had made several acquisitions within the advanced therapy space. Alongside incorporating these new businesses, the organisation also wanted to further invest and dedicate employee resources to focus on growing the Cell and Gene field.
Training Need
The client wanted to ensure they were best placed to efficiently distribute personnel resources onto new projects within CGT to ensure effective management and improve their chances of success. They were bringing onboard many new employees from outside the organisation and internally; all of which had a different understanding of CGT/ ATMPs. For this reason, it was crucial that they had a training that ensured a common understanding of ATMPs, the basics, an overview of their regulatory and quality challenges and the clients internal processes and interpretations.
Educo Life Sciences Solution
Educo created an online, on-demand micro learning course incorporating the client’s internal processes, jargon and interpretations. Held on Educo’s LMS the training material was made of short videos, reading materials, quizzes and games to ensure an engaging approach. Individuals were given a unique log in and able to access the material at any time and location with internet. The course recorded progress so individuals could dip in and out of the training around their busy schedules. Reports of completion and activity were provided by Educo to the client’s stakeholders so they could ensure the progression of the group.
Outcome
The Educo solution enabled the client to ensure a standardised basis of knowledge for all new employees joining CGT projects so that individuals came up to speed in a fast and effective manner, enabling them to immediately contribute to projects. The format of the training also ensured an easy administration for the client and minimal impact on day-to-day roles.
Case Study 2 | Navigating the Regulations for a Gene Therapy Product
Scenario
An Educo client, a biotech start-up, had raised a significant amount of funding to support the advancement of their innovative delivery mechanism for their gene therapy therapeutics. Their pipeline contained therapeutics for the treatment of rare and severe diseases.
Training Need
The Educo client’s need for training was threefold. Firstly, their modality is a very novel so there are currently no industry examples which their technical and R&D teams could use as a framework. Secondly, there was a lack of CTD writing experience within the different teams, so they needed to improve their understanding of EMA and FDA requirements. Thirdly, the regulations for their novel modality-based therapeutic is a grey area. It was either classified as a cell & gene therapy or biologic. The client wanted their R&D teams to receive a recurring training course focused on early development.
Educo Life Sciences Solution
Educo Life Sciences created a comprehensive and customised on-site training workshop built around the client’s objectives, processes and modalities, delivered on-site at client’s premises. For the workshop the analytical and process teams worked together to conduct two joint mock exercises to assess and design process change comparability studies and method tech transfers.
Outcome
The Educo solution enabled the client to ensure an aligned level of knowledge across their analytical and process teams for early development, becoming well-versed in Regulatory requirements and interpreting guidance documents, and successfully contributing to the advancement of the client’s novel modality-based therapeutics pipeline.
Team Training Customers
