This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No 955756.

In-Pharma-tion “Regulatory approval of new medicines” ESR workshop

Gothenburg, Sweden, 13. – 14. October 2022

The second In-Pharma-tion workshop is organised our partner AstraZeneca in Sweden titled “Regulatory approval of new medicines”. InPharma consists of 11 Beneficiaries uniting world-leading academic research groups and pharma companies on their common search for better drug formulation processes which lead to safer and more efficient drugs for patients while simultaneously eradicating animal testing from the process and reducing development costs. 

Day 1: Exhibition of the facilities incl manufacturing plant

 

Afternoon/evening: tour of the facilities and social activity

13:00-14:00

Welcome and The amazing journey
Anders Borde, AstraZeneca Gothenburg

14:00-14:30

Break

14:30-15:30

Manufacturing plant
Elsa Tanneby & Frederika Bramer, AstraZeneca Gothenburg

15:30-17:00

Social activity

18:00

Dinner


Day 2: Lectures

 

Morning session

8:30-9:15

Bridging /bioequivalence
Dr. Helena Engman, AstraZeneca Gothenburg

9:15-10:00

In silico modelling: case example
Dr. Christer Tannergren, AstraZeneca Gothenburg

10:00–10:15

Break

10:15–11:00

Justification of clinically relevant QC specifications
Dr. James Mann, AstraZeneca UK

11:00–11:45

Advanced dissolution tools in regulatory submissions
Richard Barker, AstraZeneca UK

11:45–12:30

A regulatory view on In silico modelling in regulatory submissions
tbc, MPA

12:30–13:30

A regulatory view on In silico modelling in regulatory submissions
tbc, MPA

 

Afternoon session

13:30–14:15

Control strategy
Mikael Thune & Anette Skoog

14:15–15:00

Turning scientific knowledge and understanding into a regulatory submission
Vivien McAlpine

15:00–15:30

Break

15:30–16:15

CMC Reg Affairs: The Future of CMC Submissions
Dr. Gregory Rullo, AstraZeneca Gothenburg

16:15–16:30

Wrap-up and discussion
All participants

Main contacts


Sara Carlert, AZ
Main organiser


Eva Karlsson, AZ

Main organiser

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