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Industry-Leading Workshop on the EU AI Act, Sept. 2025

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As the EU’s landmark Artificial Intelligence Act enters its first phase of legal enforcement, the stakes have never been higher for businesses building, deploying, or integrating AI systems across the European market. That’s why we’re proud to announce that Dr. Galya Mancheva, CEO of AI Advy, will lead a full-day professional training titled “The EU AI Act: How to Comply with the New Obligations When Working with AI”, Organized by Alpha Quality. 


The event will take place on September 3, 2025, 9:00 AM – 5:00 PM in Sofia Tech Park.

The EU AI Act is the first comprehensive AI regulation in the world, and its reach goes far beyond Big Tech. Companies in finance, HR, education, health, logistics, and public services are now facing strict obligations, particularly those using or developing high-risk AI systems.

From CV-screening software and credit scoring models to identity verification tools and emotion recognition, if your AI affects human rights, safety, or access to essential services, you are subject to the AI Act.

Yet many companies still don’t know:

  • Whether they fall under the Act

  • What documentation and risk assessments are required

  • What penalties exist for non-compliance

  • How to practically implement oversight and monitoring

What You’ll Learn in This Seminar

Led by Dr. Mancheva, this workshop will provide clear, practical, and actionable guidance on:

  • 🔎 Identifying whether your system is high-risk (Annex III classification)

  • 📝 Creating and maintaining legally required technical documentation

  • 🧑‍⚖️ Understanding conformity assessments and the role of the future EU AI Office

  • 🧭 Implementing human oversight, transparency, and post-market monitoring

  • ⚠️ Avoiding common legal traps and regulatory blind spots

Participants will walk away with a practical roadmap, sample templates, and first-hand insight into what compliance looks like across sectors.

About Dr. Galya Mancheva

As the CEO of AI Advy, Dr. Mancheva has advised governments, regulatory bodies, and private companies on the intersection of AI, law, and ethics. She is a board member of the Bulgarian Association of Information Technologies (BAIT) and has contributed to EU policy discussions around responsible AI deployment. Her approach is known for bridging legal theory with real-world business realities.

How to Register

Spots are limited and early registration is recommended.
📍 Visit Alpha Quality’s official event page for full details and sign-up.

Whether you’re in compliance, product development, legal, or innovation leadership, this seminar is your chance to get ahead of what will be the most impactful tech regulation of the decade.

How the EU AI Act Is Changing Business and Citizen Protection

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On the 7th of June, Dr. Galya Mancheva appeared on Bulgaria ON AIR to discuss the impact of the EU AI Act on business and citizen protection. In her capacity as board member of the Bulgarian Association of Information Technologies (BAIT), she explains how the European Union’s Artificial Intelligence Act will reshape business practices and enhance citizen protection. As one of the first comprehensive legal frameworks on AI globally, the Act introduces new standards that apply not only to companies within the EU but also to international businesses whose AI systems reach European users.

 

In the interview, Dr. Mancheva highlights how the new regulation brings the needed clarity by categorizing AI systems by risk and setting clear rules around transparency, safety, and accountability. She emphasises that the AI Act is not a barrier to innovation, but a foundation for building trust and ethical AI practices in the EU. Dr. Mancheva urges companies to move beyond fear and embrace AI, emphasizing that the EU AI Act is designed to ensure all stakeholders can benefit from AI in a safe and well-regulated environment. She emphasises the importance of business readiness, warning that many Bulgarian companies are still behind in adapting to the upcoming legal requirements. BAIT is working actively to raise awareness and help businesses align with the new standards.

 

Some of the consequences of failing to comply to the Act are also mentioned. The regulation allows for fines of up to €35 million or 7% of a company’s global annual turnover, depending on the nature and severity of the violation. But beyond the financial risk, Dr. Mancheva notes that companies also face reputational damage if they are found to be using AI irresponsibly.

 

A big focus of the interview is how the AI Act also plays a crucial role in protecting individuals. It guarantees that EU citizens have the right to know when they are interacting with AI and ensures their personal data is not being misused or exploited by black box algorithms. By banning the most dangerous applications and demanding transparency from high-risk systems, the regulation aims to build public trust in AI technologies.

 

Dr. Mancheva compares the regulation to simple traffic rules. “If we want to have many cars on the road,” she said, “we need clear rules that protect both drivers and pedestrians. That’s the only way we can all move forward safely.” In the same way, the AI Act creates a safe structure in which innovation can flourish without putting fundamental rights at risk.

Dr. Mancheva believes that the AI Act is carefully structured, under the guidance of many global business and political figures, focusing on the message that innovation should never come at the expense of accountability and human rights. She sees the AI Act not as a limitation, but as a framework for building responsible technology that serves both individuals and businesses.

 

AI Innovation and Risk Management in the Public Sector

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In a recent presentation hosted by NDB, Dr. Galya Mancheva explored the transformative role of AI in the public sector and the urgent need for ethical governance.  She called on government institutions to lead by example in adopting AI responsibly and transparently.

Dr. Mancheva explained that while AI offers new opportunities for public administration (from predictive policy tools to digital citizen services) its use must be rooted in strong internal controls and public accountability. Unlike in the private sector, decisions made with AI in public institutions often touch on basic rights, such as access to healthcare, education, or social support.

“Governments must show what responsible AI looks like,” said Dr. Mancheva. “When AI is used to make decisions that affect citizens’ lives, transparency, fairness, and human oversight are non-negotiable.”

She stressed that the EU AI Act provides the tools to ensure this happens. By categorizing AI systems by risk and requiring transparency from high-risk applications, the Act protects citizens while allowing space for innovation. In the public sector, this means guaranteeing that people know when they are interacting with AI and that their data is handled with care.

Dr. Mancheva also emphasized the need for national strategies that combine innovation with risk awareness. She warned that without proper governance, the public sector risks losing citizen trust, especially if algorithmic decisions go unchecked.

AI Innovation and Risk Management in the Financial Sector

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In the beginning of June, Dr. Galya Mancheva spoke at an event hosted by NDB, addressing the growing impact of AI on Bulgaria’s financial sector, as she outlined how the European Union’s Artificial Intelligence Act offers a critical framework for balancing innovation with responsible risk management.

Dr. Mancheva emphasized that financial institutions have much to gain from AI adoption. The financial sector covers a lot of ground, from automating customer service and enhancing fraud detection to optimizing credit scoring. However, a warning was made that the benefits of AI can only be realized when systems are transparent, explainable, and aligned with legal and ethical standards.

She pointed out that many financial firms still rely on black-box models that risk introducing bias or error, particularly in decisions that affect people’s financial rights. Under the EU AI Act, such high-risk applications will require rigorous documentation, transparency, and accountability measures.

“This is not about slowing innovation. It’s about building trust. AI systems in finance must be safe, fair, and explainable, especially when they affect real lives.”

Dr. Mancheva further noted that the AI Act sets a new compliance benchmark, with potential fines reaching €35 million or 7% of global turnover for violations. But the true cost, she argued, is reputational: companies seen as irresponsible in their AI practices may lose the trust of both clients and regulators. The AI pioneer urges financial institutions to act now, not later, and to treat regulatory readiness as part of their innovation strategy.

EU AI Act Compliance: A Step-by-Step Guide for Businesses

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With the EU AI Act now in force, businesses deploying AI must ensure compliance or risk heavy penalties. But what does compliance actually involve? This guide breaks down key requirements and practical steps to help organizations align with the new regulations.

Understanding Your AI Risk Category

The EU AI Act classifies AI systems into four categories:

  • Unacceptable Risk (banned, e.g., social scoring)
  • High Risk (strict compliance needed, e.g., AI in hiring & healthcare)
  • Limited Risk (transparency requirements, e.g., chatbots)
  • Minimal Risk (no additional obligations)

Action Step: Businesses must audit their AI systems to determine their risk level and compliance obligations.

Key Compliance Requirements for High-Risk AI

If your AI system is high-risk, you must ensure:
– Data governance – AI must be trained on high-quality, unbiased data
–  Transparency & explainability – Users must understand how AI makes decisions
– Human oversight – AI systems cannot operate without human intervention

– Robust security measures – Cyber resilience is mandatory

 Action Step: Develop a compliance roadmap to document your AI’s training data, risk mitigation strategies, and monitoring process.

 How to Prepare for AI Act Compliance Audits

EU regulators will conduct strict audits on high-risk AI systems. Companies should:
–  Perform internal AI audits before regulatory inspections
–  Create a risk management framework tailored to their AI use case
–  Maintain detailed compliance documentation

 Action Step: Work with AI compliance experts to ensure your AI systems meet legal standards before audits begin.

Penalties for Non-Compliance

The EU AI Act enforces steep fines for violations:
– Up to €35 million or 7% of global annual turnover for non-compliance with banned AI practices
– Up to €15 million or 3% of turnover for failing to meet high-risk AI requirements

Action Step: Invest in AI compliance consulting to avoid costly penalties and reputational damage.

Navigating AI regulation is complex, but compliance is a business necessity. Partnering with AI Act experts ensures your business stays ahead of regulatory changes while leveraging AI safely and ethically.

Dr. Galya Mancheva Showcased AI Compliance Leadership at AI Innovation Summit

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Sofia, March, 6th – Dr. Galya Mancheva, a leading expert in AI compliance and CEO of AI Advy, recently participated in the prestigious AI Innovation Summit, where she shared valuable insights on AI regulation and ethical AI implementation.

At the summit, Dr. Mancheva addressed the critical challenges businesses face in navigating the EU AI Act and ensuring compliance with evolving AI regulations. Her participation underscored the importance of ethical AI development, risk mitigation, and corporate responsibility in AI adoption.

“The AI Innovation Summit was an incredible opportunity to exchange ideas with industry leaders and policymakers,” said Dr. Mancheva. “As AI continues to transform industries, ensuring compliance and ethical deployment is essential for long-term success and public trust.”

As the CEO of AI Advy, Dr. Mancheva leads efforts to help businesses integrate AI governance frameworks and align their AI systems with regulatory standards. Through her expertise, she is shaping the future of AI compliance and innovation in Europe and beyond.

For more information about Dr. Galya Mancheva and AI Advy, visit ai-advy.com or contact :mancheva@ai-advy.com.

 

The EU AI Act: A Bold Step or a Bureaucratic Nightmare?

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The European Union’s AI Act is the world’s first comprehensive attempt to regulate artificial intelligence. While its intentions are noble—ensuring ethical AI and protecting citizens—it has sparked intense debate. Is the EU leading the way in responsible AI development, or is it setting up barriers that will stifle innovation? This paper explores the key elements of the AI Act, its potential consequences, and whether it will shape the global AI landscape or leave Europe lagging behind.

Introduction: The AI Wild West and the EU’s Gamble

AI is advancing at a breakneck pace, transforming industries, economies, and societies. While the U.S. and China are engaged in an AI arms race, the EU has taken a different path—opting for strict regulation. The AI Act, first proposed in 2021 and finalized in 2024, aims to create a “human-centric” approach to AI governance. But can regulation keep up with technology, or will it be a self-imposed handicap?

 The Core of the AI Act: Risk-Based Regulation

The AI Act classifies AI systems into four categories based on their risk level:

Unacceptable Risk: Banned outright (e.g., social scoring, mass surveillance, emotion recognition in workplaces).

High Risk: Heavily regulated (e.g., AI in healthcare, hiring, law enforcement).

Limited Risk: Transparency requirements (e.g., chatbots, AI-generated content).

Minimal Risk: No special restrictions (e.g., video game AI, spam filters).

On paper, this seems reasonable, but critics argue that the real problem isn’t regulation itself—it’s the bureaucracy that comes with it.

 The Innovation Paradox: Protecting or Choking AI Development?

Europe prides itself on ethical AI, but will companies simply move elsewhere? Many AI startups and tech giants claim that the AI Act will make it nearly impossible to compete with less regulated regions like the U.S. and China.

DeepMind and OpenAI executives have warned that excessive regulation will make the EU unattractive for AI research.

EU-based AI startups fear they will drown in compliance costs while Silicon Valley races ahead.

France and Germany, despite supporting the Act, have lobbied for looser rules for general-purpose AI (GPAI) models like ChatGPT.

The irony? While the EU is enforcing strict AI rules, many of its top AI researchers and companies are moving to the U.S., where AI investment is skyrocketing.

The Enforcement Problem: Can the EU Keep Up?

The AI Act introduces heavy fines (up to €35 million or 7% of global turnover), but enforcement will be tricky. AI models evolve too fast for regulators to track, and determining AI “risk” isn’t always clear-cut. The Act also requires AI developers to document and explain their models—something that’s difficult, if not impossible, with complex neural networks.

Imagine trying to regulate an AI that constantly rewrites itself. Can regulators really audit something that even its creators barely understand?

 The Geopolitical Game: Europe vs. the World

While the EU is tightening its grip on AI, other global players are taking different approaches:

The U.S.: Focusing on voluntary AI safety commitments rather than strict regulations.

China: Prioritizing AI dominance with state-controlled guidelines.

UK and Canada: Opting for a more flexible, innovation-friendly AI governance model.

The EU wants its AI Act to set the global standard, much like its GDPR privacy rules. But will other nations follow, or will they leave Europe behind in the AI race?

 Conclusion: The Future of AI in Europe

The AI Act is a bold experiment—one that could make the EU a leader in ethical AI or turn it into an overregulated, innovation-hostile zone. The next few years will determine whether the Act ensures AI safety without suffocating progress or whether Europe’s most ambitious tech policy becomes a cautionary tale.

One thing is clear: while the AI revolution is unfolding, the EU is betting big on rules. The question is—will those rules make or break its future?

 

How the EU AI Act impacts Business Opportunities and Challenges

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The European Union’s AI Act is more than just a regulatory framework—it’s a transformative shift that businesses need to navigate strategically. While much of the discussion has focused on compliance and restrictions, there are also significant opportunities for innovation, competitive advantage, and market leadership.

New Business Opportunities in AI Compliance

The AI Act introduces rigorous transparency, risk assessment, and compliance requirements. This creates a demand for specialized services such as:

  • AI compliance consulting: Companies helping others audit and align their AI systems.
  • AI governance software: Tools that monitor, document, and ensure compliance in real-time.
  • AI Ethics & Bias Auditing: Services to assess and mitigate biases in AI models.

Startups and established firms in these areas will find a growing market as companies race to meet new regulatory demands.

Competitive Advantage for AI-Ready Companies

Companies that proactively integrate ethical AI principles, transparency mechanisms, and risk mitigation strategies will gain a first-mover advantage. Businesses that demonstrate compliance early may benefit from:

  • Faster approval processes when selling AI-driven products in the EU.
  • Enhanced trust from customers, investors, and stakeholders.

A stronger position in international markets, as the EU AI Act is expected to influence global AI regulations.

Impact on Startups and SMEs: Regulatory Sandboxes

The AI Act includes regulatory sandboxes—controlled environments where startups and SMEs can test AI models under regulatory supervision before a full-scale launch. This is particularly beneficial for:

  • Healthtech: AI-driven diagnostics or personalized medicine.
  • Fintech: AI models for risk assessment and fraud detection.
  • Edtech: AI-powered learning platforms and assessments.

Access to regulatory sandboxes allows businesses to refine their AI without immediate risk of penalties, fostering innovation in highly regulated industries.

Generative AI and Intellectual Property Implications

For businesses leveraging generative AI, transparency obligations under the AI Act mean:

  • Companies using AI to generate content must disclose that it is AI-produced.
  • Large AI model providers must clarify the data sources used for training, addressing copyright concerns.

This creates a new content authentication industry, where companies can provide digital watermarking, AI verification tools, and traceability solutions.

Impact on Hiring and Workforce Strategy

With the AI Act emphasizing human oversight in high-risk AI systems, businesses will need to invest in:

  • AI risk management professionals to oversee compliance.
  • AI ethicists to ensure responsible AI development.
  • Cross-functional AI governance teams to manage implementation.

Preparing for the Future: Action Steps for Businesses

To stay ahead of the EU AI Act, businesses should:

  • Conduct an AI risk assessment to determine compliance obligations.
  • Implement AI transparency policies and documentation procedures.
  • Explore partnerships with AI ethics and compliance firms.
  • Invest in AI upskilling programs for employees.
  • Monitor future AI legislation in other regions that may follow the EU’s lead.

A Shift from Regulation to Opportunity

While the AI Act imposes new rules, it also shapes the future of AI-driven businesses. Companies that embrace these changes strategically can turn compliance into a competitive advantage, position themselves as leaders in ethical AI, and unlock new revenue streams in AI governance and risk management.

Businesses that view the AI Act not as a hurdle, but as a market differentiator, will be the ones that thrive in the new AI-powered economy.

The EU AI Act: A Catalyst for Ethical AI and Business Transformation

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The EU AI Act is not just a regulatory hurdle – it’s a game-changer for AI-driven innovation. Businesses across industries are rethinking their AI strategies to align with compliance, ethics, and responsible AI adoption. But beyond legal obligations, the Act presents an opportunity: companies that adapt early can lead the future of ethical AI innovation.

Key Changes: How the EU AI Act is Reshaping AI Development

High-Risk AI: More Oversight, More Trust

Under the Act, AI systems used in finance, healthcare, HR, law enforcement, and education are classified as high-risk. These systems must:

  • Undergo rigorous risk assessments and bias testing
  • Ensure human oversight in decision-making
  • Provide clear documentation and explainability

What This Means for Businesses:
Companies must redesign AI models to be more interpretable and auditable, shifting the focus from “black-box AI” to trustworthy AI.

Transparency & Accountability: The New AI Standard

One of the Act’s most impactful requirements is transparency. AI providers must:

  • Disclose training data sources (to prevent bias and copyright violations)
  • Label AI-generated content to prevent misinformation
  • Implement strong governance frameworks for continuous monitoring

The Business Impact:
AI leaders who invest in ethical AI development will win consumer trust and differentiate themselves in the market.

General-Purpose AI (GPAI): The Next Big Challenge

Foundation models and large-scale AI systems (such as ChatGPT, Gemini, and Claude) must comply with:

  • Risk mitigation plans to prevent harmful applications
  • Increased scrutiny on AI-generated content (deepfakes, misinformation, etc.)
  • Audit requirements for bias and safety

The Innovation Shift:
Big Tech and AI startups must balance innovation speed with ethical safeguards, leading to more responsible AI models.

What’s Next? The Future of AI Innovation in Business

The EU AI Act is a turning point for AI-driven industries. Businesses that embrace compliance as a competitive advantage will lead the next era of trustworthy and ethical AI.

Dr. Galia Mancheva will speak at EEGS Webinar on AI’s Impact in Gaming

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February, 19th – Dr. Galia Mancheva, a leading expert in AI regulation and compliance, will be a featured speaker at the upcoming EEGS Webinar: “Rolling the Dice on AI: How Artificial Intelligence is Reshaping the Gaming Industry”, taking place on February 19, 2025, at 1:00 PM (EET).

As AI continues to revolutionize iGaming, its role in player experiences, responsible gambling, and regulatory compliance is more critical than ever. Dr. Mancheva will provide expert insights into the EU AI Act’s implications for the gaming sector, highlighting key regulatory challenges and ethical considerations.

“I’m excited to join this discussion and shed light on how AI can drive innovation while maintaining ethical and responsible gaming standards,” said Dr. Mancheva. “As regulations evolve, businesses must align with compliance requirements while harnessing AI’s potential to enhance user experiences.”

The EEGS Webinar will bring together industry professionals, policymakers, and AI experts to explore the opportunities and risks AI presents in gaming. Key topics include the intersection of technology and responsible gambling, the future of AI-driven regulation, and how operators can stay ahead in an increasingly automated landscape.

Registration for the event is now open. For more details and to secure a spot, visit : https://us06web.zoom.us/webinar/register/WN_igaHu5GHQ2SNHkD4s9J92g

About Dr. Galia Mancheva
Dr. Galia Mancheva is a recognized authority in AI governance and compliance, specializing in the EU AI Act and its impact on businesses. She is actively involved in shaping responsible AI policies, helping companies navigate regulatory challenges in emerging industries.