4freeCLE: free continuing legal education: November 11: Understanding the FDA Pathway: Regulatory Basics for Biomedical Device Innovators

Wednesday, October 1, 2025

November 11: Understanding the FDA Pathway: Regulatory Basics for Biomedical Device Innovators

This presentation is designed to help break down the FDA premarket submission process into a practical foundation, explaining fundamentals of device classification, the key premarket submission pathways, and the strategic considerations that can help you avoid common pitfalls and set your product up for success.

Title:
Understanding the FDA Pathway: Regulatory Basics for Biomedical Device Innovators

Webinar Date+Time:

Tuesday, November 11, 2025
12:00 – 12:30 p.m.
Free Continuing Legal Education Webinar - Register Now!

Credit:

CLE is approved in NY, PA, TX, IL, NV, and CA. MN CLE has been applied for approval. You may be able to self-apply for credit in some other states.

Speakers:
Aselle Kurmanova, Member, Cozen O'Connor
Danielle E. Sapega, Member, Cozen O'Connor

By:

Cozen O'Connor, established in 1970 and ranked among the top 100 law firms in America, has 750 attorneys who help clients manage risk and make better business decisions.

More Information And Registration

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October 24: The United Nations At 80 (CLE)(ad)

Eighty years ago, the United Nations was born from the ashes of global conflict with a bold mission: to maintain international peace and security, promote human rights, and uphold the rule of law. As the world faces escalating crises — from climate change to armed conflict, from mass displacement to democratic backsliding — the UN’s role is under renewed scrutiny.

This timely and thought-provoking CLE program brings together leading international law scholars and practitioners to examine the evolving role of the United Nations in today’s complex global landscape. Through expert insights and real-world case studies, we’ll explore:

🌐 The UN’s enduring contributions to international law and human rights

⚖️ The International Court of Justice and the prosecution of genocide

📊 Assessing the effectiveness of UN missions and programs

🔍 The practical value of UN bodies — such as the Aarhus Convention Secretariat — to legal practitioners, NGOs, and civil society

🧭 Whether the UN remains fit for purpose in the 21st century

Featured Faculty:

Alejandra Gonza, Executive Director, Global Rights Advocacy; former senior attorney at the Inter-American Commission on Human Rights and staff attorney at the Inter-American Court of Human Rights; A leading voice in international human rights litigation and UN engagement.
Teresa Felizia Mayr, Legal Officer, Aarhus Convention Secretariat, Environment Division, United Nations Economic Commission for Europe Expert in environmental democracy and international treaty implementation.
Professor Anita Ramasastry, former Chair of the United Nations Working Group on Business and Human Rights, currently serving on the UN’s Open-Ended Intergovernmental Working Group drafting a treaty on business and human rights; Henry M. Jackson Professor of Law and Director, Sustainable International Development Graduate Program, University of Washington School of Law.
Professor William A. Schabas, Professor of International Law, Middlesex University, London. One of the world’s foremost authorities on genocide and international criminal law; former member of the UN Commission of Inquiry on the Gaza Conflict and author of more than 20 books including "Genocide in International Law" and "The UN International Criminal Tribunals: The Former Yugoslavia, Rwanda and Sierra Leone".

🎓 This program is designed for attorneys, human rights advocates, international law practitioners, and anyone working with or within global institutions.

📩 Space is limited. Reserve your spot today and be part of this historic legal commemoration.

Lawyers For American Democracy

As lawyers, we have a duty to defend the foundational principles that have made the United States a leader of the free world for over two centuries. Yet our democracy is rapidly backsliding, putting core constitutional tenets—due process, separation of powers, and the rule of law—at risk.

When these principles are under attack, our oaths compel us to speak out, our training equips us to safeguard democracy, and our ethical obligations demand action. Now, more than ever, we must lead with conviction and example.

This is why Lawyers For American Democracy launched Meeting the Moment – A Call for Lawyers to Lead.

Learn More!

Wednesday, October 1, 2025

November 11: Understanding the FDA Pathway: Regulatory Basics for Biomedical Device Innovators

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