CRED Generics: Understanding the Regulatory Considerations

Time

Topic

Speaker

o Nonclinical data and references (Module 4) o Clinical data and references (Module 5)

• Overviews and Summaries for generics –what reviewers want to see

14.40

Regulatory strategy for a generic pharmaceutical • Complexities involved when considering the regulatory strategy • Legal basis • Choosing the Reference product • The Bioequivalence question • Summary Product Characteristics • Which application procedure to use • How good is your dossier

Peter Embley VCLS

15.50

Case Study and feedback session

Natalie Beasley Concordia International

16.50

Conclusion

All

17.00

Close of Day

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