Tailored Training Solutions:
BPS provides fully tailored training solutions developed around your specific needs. Our training packages are constantly evolving and not limited to a select suite of pre-defined content areas.
To understand the full scope of what could be put together for you, examples of training content developed within the areas of Regulatory Due Dilligence and GCMP can be reviewed below.
Full PDF downloads can also be viewed by selecting the appropriate links:
Regulatory Due Diligence Course Overview:
The knowledge and skills of Regulatory Affairs professionals are important and integral elements of any pharmaceutical business. There are many situations where these talents are needed by other parts of the business. One of these is in the area of Regulatory Due Diligence. A systematic and thorough Due Diligence process is vital in maintaining and expanding on your business capabilities, which is top of mind for senior pharmaceutical executives.
This course will work through the most common scenarios such as licence acquisition or divestment and company take over.
Participants will gain an in‐depth understanding of the Due Diligence process including:
· Performing a Gap analysis of the data
· Rate limiting headlines: What are they and how will they affect the project?
· Estimating the work required to obtain a dossier fit for the TGA
· Assessing and communicating the likelihood of approval
· Best case and Worst case scenarios
· Communication strategies internally and externally
· Timing of submission
· Likelihood and timing of approval
This course will empower Regulatory Affairs professionals to contribute significantly to the due diligence process, to the increased benefit of their business, and their working relationships. In addition to this, the course is also useful for other areas of the business in understanding how Regulatory Affairs can help them.
Download full course PDF here
GCMP Course overview:
Familiarisation with clinical trials, why they are required and the obligations of both the sponsor and the manufacturer when entering into a Commercial and Technical Contract to manufacture an investigational medicine.
Elaborate on the different phases of a clinical trials and the cGMP requirements
Define the terms blinding, placebo and randomisation as they affect a clinical trial
Outline the requirements for FDA and TGA cGMP compliance
Outline the GMP requirements for the manufacture of materials for clinical trials and list risk management strategies to correctly introduce a clinical trial into a business
Outline the key GMP requirements for the packaging and labelling of materials for clinical trials
Identify sources of errors and mix ups in the distribution of material for clinical trials
Labelling requirements for IMP in the US, EU and Australia
Outlining the links between GMP and GCP and how this interaction can influence the trial
Action based learning scenarios developed from company experiences to reinforce the above
Download full course PDF here.