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