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Standards & Regulation

Business & Regulation Advanced Medicine

FDA Quackdown

| James Strachan

Regulators step in to stop stem cell clinics from marketing unproven therapies.

Discovery & Development Biosimilars

What Regulators Want

| Bruno Speder

The path to market for a biosimilar involves an abbreviated approval process, focused on proving “biosimilarity”.

Manufacture Standards & Regulation

Stay Ahead. Smart Risk Management

Collaboration is crucial for supply continuity and control.

Manufacture Facilities

Keeping Fit With Age

| Sponsored by CRB

Proactive stress testing is a must to keep facilities fit and healthy.

Business & Regulation Business Practice

Let’s Get Ready to Serialize!

| James Strachan

Are pharma companies ready for the upcoming serialization deadlines?

Discovery & Development Business Practice

Gearing up for GDPR

| Roisin McGuigan

New data protection regulations are coming.

Business & Regulation Technology and Equipment

Easy as eCTD?

| Pallavi Trivedi

Deadlines for mandatory eCTD transitioning are approaching!

Business & Regulation Standards & Regulation

No Better Time to Be Humble

| Bruno Sepodes

Sitting Down With Bruno Sepodes, Professor of Pharmacology and Pharmacotherapy, University of Lisbon.

Manufacture Standards & Regulation

Raising the Biosimilar Banner

| Stephanie Sutton

FDA Commissioner Scott Gottlieb wants more biosimilars on the US market.

Business & Regulation Business Practice

Towards Transparency

| James Strachan

Health Technology Assessments are a way of life for the pharma industry, but are all HTAs equal?


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