€175 – €350

Dublin City University Pharmaceutical Regulatory Symposium & Webinar

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Location

DCU Alpha Campus

Innovation Campus

Old Finglas Road

Glasnevin

Ireland

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Refunds up to 1 day before event

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Description


Dublin City University Pharmaceutical Regulatory Symposium & Webinar



“Exploring Current Trends in Active Pharmaceutical Ingredients Manufacture, Control and Regulation”


DCU Alpha Campus, Dublin – 09th May 2018


Overview

Regulatory Science Ireland, in partnership with Dublin City University (DCU), and DCU Alpha (DCU's innovation campus) are pleased to present the second symposium on Active Pharmaceutical Ingredients on 09th May 2018, in Dublin, Ireland.

Again this second symposium will bring together high calibre regulators and industry experts to discuss the current trends in the manufacture, control and regulation of active pharmaceutical ingredients (API’s).

The symposium will serve as a unique discussion platform for industry and regulatory professionals, as well as providing a valuable learning opportunity for junior professionals, junior regulators and members of academia.


Participants can attend the symposium on the day at the DCU Alpha campus, or can register online to view the event as a webinar.



Key benefits - why should you attend?

This symposium will serve as an open and inclusive forum to discuss the latest regulatory guidance and emerging trends, presented by European regulators and industry experts.

The event will appeal to regulatory professionals, regulators, members of academia, and scientists interested and/or involved in the manufacturing and regulation of active pharmaceutical ingredients.


Attendees will have the opportunity to learn about a wide range of topics which include:

● Latest developments on regulatory aspects of API manufacture


● The use of “risk management” as a tool when developing a control strategy for a drug substance.


● Translation of process knowledge into a regulatory dossier to reduce probability of deficiency letters.


● Use of the recently published ICH Q11 question and answer document to help you define an appropriate starting material for your process.


● Identification and control of risks associated with mutagenic impurities and/or elemental impurities during the manufacturing process.



● Emerging technologies and application of flow chemistry in API manufacture.




Theme & Topics

Exploring current trends in API manufacture, control and regulation”


For the 2018 edition, topics have been selected in order to address the most common issues encountered in active substance master files and/or CEP applications.

Some topics delve further in order to discuss new guidance recently published in the last year (e.g. application of the ICH Q11 question and answer document).

In addition, we will also explore the emerging trend of continuous manufacturing and the potential impact in API manufacturing control and regulation.


The symposium will focus on 5 core topics based upon the principles ICH regulatory guidance:

1. The principles of Quality Risk Management as Outlined in ICH Q9

2. Definition of an Appropriate Starting Material for Your Active Substance as per ICH Q11. Interpretation and application of the recently published ICH Q11 question and answer document.

3. Strategies for Management of Potentially Genotoxic/Mutagenic Impurities as per ICH M7

4. Strategies for Management of Elemental Impurities using the principles outlined in ICH Q3D

5. Principles of Flow Chemistry and Continuous Manufacturing in API Manufacture and Control.



Keynote Speakers

Dr. Michael Morris (HPRA Retiree) - Symposium Chair:

Ms Ciara Turley (HPRA) - The principles of Quality Risk Management as Outlined in ICH Q9

Mr Matt Popkin (GSK) - Definition of an Appropriate Starting Material for Your Active Substance and interpretation of the ICH Q11 Question and Answer Document

Mr. Ciarán Feeney (EDQM) - Strategies for Management of Potentially Genotoxic/Mutagenic Impurities as per ICH M7

Dr Michael James (Consultant) - Strategies for Management of Elemental Impurities using the principles outlined in ICH Q3D guideline

Dr. Aoife Corrigan (Eli Lilly) - Principles of Flow Chemistry and Continuous Manufacture in the Production of Active Pharmaceutical Ingredients.




Schedule

Timetable of Events




Location

DCU Alpha Campus, Innovation Campus, Old Finglas Road, Glasnevin, Dublin 11, Ireland (See map at bottom of page).

How to get there:

Dublin Bus 83 stops at the campus gates and a wide variety of bus stops are within short walking distance from the facility.

Parking is available in the visitors car-park via the Old Finglas Road, this is managed on a first come first served basis.



Contact

Querys should be addressed to the Organising Committee at apisymposium@dcu.ie





Organising Committee

Mr. Ciarán Feeney – European Directorate for the Quality of Medicines and Healthcare (EDQM)

Dr. Michael Morris – Health Products Regulatory Authority (HPRA) Retiree

Dr. Michael James – Consultant

Dr. Kieran Nolan – Dublin City University School of Chemical Sciences

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Date and Time

Location

DCU Alpha Campus

Innovation Campus

Old Finglas Road

Glasnevin

Ireland

View Map

Refund Policy

Refunds up to 1 day before event

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