BMS5009 – Ethics Presentation
1. what are some ethical issues the company faces?
2. Is there an ethical framework that our company/ any
pharmaceutical company must follow in Australia?
3. Do the guidelines provided by the TGA count as ethical guidelines?
4. Does confidentiality of the agreements between the company and
various parties come under ethics?
What have I done so far during my internship:
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Created DPAs and coversheets for various clinical sites
Filled out site monitoring visits for various sites regarding the SN38
trials
Cleaned up some data for the patients
Starpharma:
Environment, Social & Governance Framework (ESG)
As a biopharmaceutical company, Starpharma is uniquely positioned to help address global health
challenges, by bringing important medicines and health products to patients in need. We
acknowledge this important role and believe our innovative products will deliver long-term value to
all stakeholders.
Alongside developing important products for patients,
Starpharma is committed to ESG and to corporate
sustainability more broadly. As part of this commitment,
Starpharma releases a standalone Environment, Social
and Governance (ESG) Report each year alongside its
Annual Report.
Starpharma’s ESG report showcases how we operate
responsibly and contribute to the wider community, with
consideration for global ESG goals, principles, and
frameworks.
This report is centred around our ESG framework, which
comprises four pillars: Governance, Our People, Products
& Patient Health, and Environment. Our ESG framework is
strongly embedded throughout our business and during
the year we have continued to prioritise activities and
initiatives to achieve high standards in each of these
pillars. Several key achievements from the period are
captured in the report, highlighting our commitments to
good governance, our people, responsible supply chains,
and mitigating our impact on the environment.
Bellberry LTD for ethics
Run GCP and trials appropriately, money and everything
SAEs and how the company responds to it (using report forms)
UK is MHRA the authority that ensures this stuff
Patient confidentiality and informed consent is the biggest one for the company
Standard operating procedures (SOPs)
GDPR UK for the data protection another major factor that the company has to ensure
Safety database collects what exactly happened to the patient regarding the actual drug product
when an SAE occurs
Submitting study amendments to regulatory agencies and IRV/IEC concerning Urgent safety
measures
Starpharma ESG Report 2022 - Final.pdf