Agenda

All times displayed for Europe/Amsterdam timezone.

ICSE Theatre

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11:50 - 12:20 ICSE Theatre
Pharma Insight Briefings

Sponsored by:

CIS Market: Regulatory Strategies in Dynamic Convergence
12:30 - 13:00 ICSE Theatre
Pharma Insight Briefings
Member of the Board
Inpharmatis, SIA

Sponsored by:

Break-through innovation in science and technology is rapidly changing the world of pharmaceuticals. In strictly regulated markets of the developed world there is a well-established structure within regulators allowing for the balance of availability of monitored for quality and safe innovative drugs to the patients. The situation in less developed with respect to regulatory scene countries is very different. Huge geographical region of CIS (Commonwealth of Independent States) representing ex-Soviet Union region and consisting of some twelve countries today is of great interest to pharmaceutical companies as one of the emerging markets. Penetration to these markets requires local knowledge of tendencies and problems. Many questions remain yet unanswered on GxP regulations, drug safety, regulatory aspects for biotech, radiopharmaceuticals, orphan drugs. However the convergence dynamics are obvious, allowing to predict the short-term future path of development and differences from the Western world. We present an analysis of the CIS market trends on regulatory affairs and drug safety for the upcoming years.

Third party voluntary evaluation of APIs and intermediates
13:50 - 14:20 ICSE Theatre
Pharma Insight Briefings

Sponsored by:

How third party systems of evaluation od APIs and intermediates applied for by manufacturers of APIs and intermediates help improving pharma supply chain in terms of better selection of supplies

Innopack & P-MEC Theatre

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12:30 - 13:10 Innopack & P-MEC Theatre
Pharma Insight Briefings