This 30 ECTS block is the second in a series of 3 Residencies that the students of Immersive Bioscience will undertake during the 3rd year of the course. Part 2 - this block will be taken by all Immersive Bioscience students MSc level students and form part of a year long residency when combined with Part 1 and Part 3 of Residency 3. The main focus of this block is continuing and on-going evaluation of project work started in Residency 3 Part 1

The students will expand their knowledge in critical aspects of the regulated working environment from study and experience of: 1. Preparing for a regulatory audit 2. EU GMP Annex 2:Manufacture of Biological Medicinal Products for Human Use

On successful completion of this module, students will be able to: 1. Analyze data generated in the project 2. Propose next steps in project/investigation 3. Demonstrate an understanding of and be able to explain the function of regulatory bodies in the context of a regulator audit 4. Explain the key requirements set out in EU GMP Annex 2 for the manufacture of Biological Medicinal Products for Human use

On successful completion of this module, students will be able to: 1. Demonstrate an appreciation of the rules and regulations for production of a Biological Medicinal Product for Human use 2. Propose solutions to posited problems 3. Report outcomes of their experimentation in a team setting 4. Revise work plan based on new knowledge 5. Ask relevant questions to gain understanding of BioPharma regulatory framework

On successful completion of this module, students will be able to: Perform project related experimentation in a safe and professional manner.

Residency 3 Part 2 is for MSc route student and the projects will be either Mentor-given or Student-selected projects (briefly outlined below). This module will comprise Months 5-8 of the extended Residency. Specialist mentors will provide 1-2 hours weekly of professionalization training in the form of information about the regulatory bodies and framework guiding the BioPharma industry. Additional training will be consistent with Industry best-practice within the Residency host organization. Student experience Each student will be responsible for their work, giving the student AGENCY while being embedded in the team of their technical mentor, and they will participate in the full activities of the team. They will attend meetings in which the team plans and evaluates its work, and coordinates with other teams producing COLLABORATIVE graduates. They will have the chance to talk to and learn from many scientists and engineers on their team, not just their technical mentor, as well as those across the rest of the organization generating ARTICULATE and CURIOUS graduates. The technical mentor will supervised the daily practical activities. Additional specialist mentors will provide weekly information sessions on the non-practical aspects of the work, for instance explain the audit process and the GMP work environment in BioPharma generating KNOWLEDGEABLE graduates. Under the joint supervision of academic and industry mentors the students will participate in periodic, cohort-based webinars open to all partners that build up the student's PROFESSIONAL expertise in a systematic way. Student teams will present and discuss with the cohort the topics prepared since the previous seminar increasing CRITICAL THINKING. Students will maintain a "logbook" that tracks their progress on the learning outcomes. Faculty are ultimately responsible for grading, and will issue grades based on (a) the student logbook (b) quality of student led webinar produced as part of the residency and (c) a report evaluated in conjunction with the industry mentor. Mentor-given project Some residencies will focus on the student's ability to take a larger project and break it down into smaller parts. In this case, they rely less on the mentor for project management, since part of the goal is for the student to take a large project with unknowns and break it down into smaller sections. An example of the scope of a Mentor-given project includes investigational studies, change control studies, method optimization, systematic development of a process or data based projects. Timeline: (these weeks correspond to Months 5-8 of the extended residency) Weeks 1-15: On-going activity for specified tasks for the extended project Student-selected project The project should be a body of work with a defined goal and substantial data generated which is of use to the mentor team. The student should analyze the data generated in their work using appropriate statistical methods and data analytic tools. It is not required that the student completely finish their project, but it is desirable that they at least be able to usefully hand over of preliminary findings to another member of their team for further work. Timeline: (these weeks correspond to Months 5-8 of the extended residency) Weeks 1-15: On-going activity for specified tasks for the extended project