Synchrocast: Understanding Brexit and its Impact on Patients

Synchrogenix's Darshan Kulkarni, Vice President, Regulatory Strategy and Policy, and Nirpal Virdee, Director, Client Services and Technology, talk about Brexit and its impact on patients. Listen in (or read the transcript) to learn more about Brexit, including the reasons behind the binary public referendum put to the United Kingdom's citizens back in 2016, and the outcome of the voting results. A ...

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Impact of the Government Shutdown on the FDA

The December 22, 2018 partial shutdown of the United States government affected roughly 25% of federal agencies, including the Food and Drug Administration (FDA), which has furloughed about 40% of its overall workforce. The duration of the shutdown is uncertain. In light of this uncertainty, it is important to understand the impact of the government shutdown on the FDA. FDA is using social medi ...

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EMA Policy 0070 External Guidance Update

Even though the European Medicines Agency (EMA) has suspended publication of clinical data through Policy 0070 due to its Brexit business continuity plan, EMA posted a Policy 0070 external guidance update on November 11, 2018. Revision 4 is now in effect. Policy 0070 External Guidance Update - Major Changes Several major changes are noted in this “Summary of Changes” document, including: Cl ...

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Synchrocast Ep 3: FDA Scrutiny Around ENDS Products

Synchrogenix's Darshan Kulkarni, Vice President, Regulatory Strategy and Policy, and Evan Richardson, Director, Regulatory Services talk about the recent FDA scrutiny around electronic nicotine delivery system (ENDS) products in this episode of Synchrocast. Evan oversees our work preparing regulatory submissions to the Center for Tobacco Products. Listen to learn more about how the FDA is attempti ...

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Synchrocast Ep 2: Narrative Writing Challenges and Approach

Synchrogenix's Tatyana Wanderer, Executive Director of Services Operations and Kelly Danyow, Associate Director of Workstream Leads have a combined 15 years of experience leading narrative projects. Listen as they discuss clients' patient narrative writing challenges and needs, and Synchrogenix's integrated and streamlined approach to narrative writing. Listen to the Synchrocast Download t ...

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