MP-E Seminars

[vc_row][vc_column][vc_btn title="Book your place here" style="outline-custom" outline_custom_color="#000d66" outline_custom_hover_background="#000d66" outline_custom_hover_text="#ffffff" align="center" button_block="true" link="url:https%3A%2F%2Fwww.makingpharma.com%2Fworkshop-getting-started-transitioning-from-document-centric-to-data-centric-drug-development%2F|target:_blank"][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]Pharma & Biotech companies around the world are now discussing a move from document-centric to data-centric development (document-centricity of course referring to pharma’s document-dependency).

However, even though companies want to move away from the document, or not be ‘document-centric’, fundamentally the industry still communicates through documents, sends information via documents etc. So, the solution (as we see it) is to not rely on the document as your source of knowledge. But, to index the content of the document, building an integrated knowledge base based on structured data frameworks where key information is Findable, Accessible, Interoperable & Reusable (FAIR). Once you have done this, the document becomes what it always should have been - an after-thought, not a priority.

In this workshop we’re going to explore a 3-step approach to indexing content (information), as opposed to indexing documents. We’ll discuss this through an example, a Quality Target Product Profile (QTPP), and we’ll look at how you might approach indexing the content of this typically huge, controlled document with the end result of building a digital-QTPP that is completely aligned with ICH Q8. Thereby shifting the point of scientific collaboration away from the document, and towards the data.

We hope that this workshop will provide new insight into the transition from document-centric development to data-centric development, and act as a source of inspiration to enact change at your respective organizations.[/vc_column_text][/vc_column][/vc_row]

15:50

[vc_row][vc_column][vc_btn title="To book a place on this workshop, please click HERE" style="outline-custom" outline_custom_color="#000d66" outline_custom_hover_background="#000d66" outline_custom_hover_text="#ffffff" align="center" button_block="true" link="url:https%3A%2F%2Fwww.makingpharma.com%2Fworkshop-making-pharmaceuticals-sustainably%2F|target:_blank"][/vc_column][/vc_row]

[vc_row][vc_column][vc_btn title="To book a place on this workshop, please click HERE" style="outline-custom" outline_custom_color="#000d66" outline_custom_hover_background="#000d66" outline_custom_hover_text="#ffffff" align="center" button_block="true" link="url:https%3A%2F%2Fwww.makingpharma.com%2Fworkshops/its-different-in-pharma%2F|target:_blank"][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]Pharmaceutical distribution is tightly regulated by the rules and regulations of GDP (Good Distribution Practice).

This session sheds light on the Rules, Regulations and Guidance that dictate Good Distribution Practice (GDP). Exploring GDP standards set by diverse regulatory bodies, we will scrutinize the similarities and differences among UK/EU GDP, WHO GDP, and FDA GDP, and ponder the differences between GDP and GMP.

Expect a dynamic session featuring succinct presentations, engaging group exercises, and lively panel discussions. Join us for an interactive session that will give you fresh insights into the contrasts, commonalities and nuances of GDP in different jurisdictions and across different regulatory bodies.

The session will be a lively, interactive mix of (brief) presentations, group exercises and panel discussions.[/vc_column_text][/vc_column][/vc_row]

[vc_row][vc_column][vc_btn title="To book a place on this workshop, please click HERE" style="outline-custom" outline_custom_color="#000d66" outline_custom_hover_background="#000d66" outline_custom_hover_text="#ffffff" align="center" button_block="true" link="url:https%3A%2F%2Fwww.makingpharma.com%2Fprotecting-people-protecting-the-environment-designing-sustainable-pharmaceutical-lifecycles-for-the-future-european-regulatory-landscape%2F|target:_blank"][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]Synopsis

Following the launch of its 2020 Pharmaceuticals Strategy for Europe, the European Commission (EC) adopted the first draft of a new directive and regulation in April 2023, opening it up to public consultation. This workshop will

• review the new environmental protections offered under the proposed legislation and the associated requirements placed upon pharmaceutical manufacturers to assess the environmental impact of the entire lifecycle of a product, from manufacturing, through use, to disposal, and
• highlight work being carried out in the ETERNAL project to visualise the interconnected system of socio-economic activity of which a typical pharmaceutical lifecycle is comprised, and to locate and assess the impacts of this activity.

Format

Short presentations will introduce both the context and substance of the proposed changes to EU legislation and the emerging results of collaborative research being presented. With the scene set, the second part of the workshop will be driven by dialogue with the audience to capture views both positive and negative on the prospective legislative changes and how new tools for process and system design, and better understanding of the environmental fate and eco-toxicological effects of pharmaceuticals can help those seeking to build compliance into their businesses. (45 minutes estimated duration)

Output

Workshop participants will benefit from a concise update on the key features of an important piece of emerging trans-national legislation and the chance to consider its implications for their own organisations. The perspectives of workshop participants from across the pharmaceuticals value chain will be captured and used by the ETERNAL project to help inform and direct work to produce a roadmap for integrating new scientific knowledge into regulatory risk assessment to target mitigations, modifications, and management strategies, ultimately towards a greener, more sustainable environment.[/vc_column_text][/vc_column][/vc_row]