MANAGING COMPLEX MULTINATIONAL SUBMISSIONS
Time: 1:00 pm
day: Workshop Day - track c PM
Details:
- Differentiating key strategic approaches between collaborating with the FDA, EMA and other health authorities
- Assessing how expedited program criteria and benefits differ between the two bodies
- Addressing key regulatory CMC differences
- Utilizing these differences to help inform clinical and manufacturing strategies
- Top tips for drug sponsors working across these different regions
Speakers:
