Transform Your Global Drug Development Approach with Insights from Certara
Developing new medicines is a global enterprise with the goal of delivering maximum positive impact on the lives of as many people around the world living with disease. Achieving success requires navigating the complex process of gaining regulatory approval and market access in multiple geographic regions amid a rapidly changing?global regulatory and commercial landscape. The Certara organization is designed to help clients not only develop the best possible medicine using modeling and simulation but to successfully navigate the global regulatory process from discovery through commercialization.??
This month's newsletter highlights the ways that Certara's experts support global health by?helping our clients achieve regulatory approval and payer acceptance in countries around the world. Certara is a global organization with team members in more than 30 countries?so whether you're interested in learning about the latest transparency and disclosure requirements for Europe, best practices for regulatory submissions for?investigational drugs for different health authorities, or technology that will help you engage payers in various regions, Certara's Inner Circle covers these topics and more.
Additionally, we are taking the all-Certara client conference, Certainty around the globe. With events in APAC and Europe this fall, our team is looking forward to sharing success stories and insights about how together, we are transforming Drug Development for good around the globe.??
Need help figuring out your drug's regulatory or commercial strategy? Contact us today!
WHITE PAPER
A Quick Guide to Understanding the new EU Clinical Trial Regulation (EU-CTR)
While the European Union Clinical Trial Regulation 536/2014 will help to streamline clinical trials, which will benefit both patients and researchers, there are some challenges for Sponsors adjusting to it. Read this white paper to learn the goals of EU-CTR along with key timelines and best practices you need to know for a successful submission.
CASE STUDY
Enhancing HEOR Global Knowledge Sharing
Discover how a leading global healthcare company revolutionized its training material distribution across multiple regions. By integrating BaseCase’s interactive platform within SharePoint, they transformed static presentations into dynamic, engaging tools. This innovative solution streamlined content distribution, improved accessibility, and set a new standard for internal communications.?
WEBINAR
RAPS Sponsored Webcast: Author Clinical Study Reports with Data Privacy & Disclosure in Mind
EMA Policy 0070 requires publishing clinical data in regulatory submissions of investigational drugs. However, this also risks compromising trial participants’ privacy or commercial trade secrets. Therefore, EMA Policy 0070 requires that sensitive data are anonymized before publication. Register for this webinar to learn about our authoring process for fast, consistent, and compliant data protection.
Date: August 7, 2024
Time: 11am - 12pm ET
BLOG
Authoring & Assembling IND and CTA Applications – Insights and Updates
Investigational New Drug Applications and Clinical Trial Applications are regulatory submissions for initiating clinical drug trials. If you’re initiating clinical trials in multiple countries, then planning for these different submissions is critical. This blog will compare the authoring of these submissions to the United States, European Union, United Kingdom, and Canada along with insights and recent regulatory updates.
WHITE PAPER
Market Access, Pricing and Reimbursement for Digital Health Technologies (DHTs) in Europe
The adoption of digital health technologies is surging in Europe because they represent innovation, potential cost savings, and align with public health priorities. However, market access, reimbursement, and patient access considerations vary across countries. Read this white paper to learn country-specific requirements and reimbursement pathways to bring a DHT to market in Europe.
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About Certara
Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries.?
Corporate Headquarters: 4 Radnor Corporate Center, Suite 350, Radnor, PA 19087 USA
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