CRED Managing Variations Effectively

Time

Activity

Speaker

Case study Tea/ coffee to be taken in syndicate groups Case study feedback and discussions Agency feedback on real Type IA rejections • Discussion on recent real examples

Lorraine Marsh Pharma Now Ltd.

14.15

15.30

Elena Razzano Pharmaceutical Assessor MHRA

16.05

16.35

Panel session

All

Chair person’s conclusion

Shilpa Jain Specialty European Regulatory Affairs Manager - Respiratory TEVA

16.55

17.00

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