SEMINAR IASMED 2013

Theme : "Moving forward for Bioscience : Focusing on Biosimilars".

PLENARY SESSION :

Moderator:  Dra. Lucky S. Slamet. M.Sc (in confirmation)

1. "The concept of biosimilars and the general principles to be applied in demonstatrting biosimilarities". Prof. dr. Rianto Setiabudy

2. "The Regulatory Aspects of biosimilar products in Indonesia".

Badan POM R.I. / Dra. A. Retno Tyas Utami, M.Epid.

3. "Clinical trials in biosimilar development". Prof. Dra. Arini Setiawati, PhD.

SESSION II :

Moderator : Dr. Biantoro Wanandi

1. "Developing biosimilars in Indonesia : Challenges and strategies to overcome".

Raymond R. Tjandrawinata, PhD (Dexa Medica)

2. "Experience with biosimilar clinical trials for product registration in Asian

countries". John Patava, PhD (Quintiles Aisa)

3. "Developing biosimilars : Technical challenges int he product development and

regulatory requirements". Speaker from Roche.

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