Mexico is making proactive and systematic strides towards shaping the future of the pharmaceutical industry within the country and ambitiously across the entire region.

The “Estrategia de Certidumbre Regulatoria 2022-2030” (Regulatory Certainty Strategy) was recently presented by COFEPRIS. This well-defined strategy ultimately aims to enhance access to therapies in Latin America. This strategy recognizes the need for local market growth and emphasizes the importance of fostering interconnections within the region, across the continent, and globally.

The Mexican edition of the forum highlights investment as a crucial catalyst for promising growth, elucidates the investment sector’s interests and concerns, and provides proactive measures to navigate the upcoming COFEPRIS-defined scenario effectively.


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Who will
you meet?


More than:









Service Providers

Government Agencies

Industry Executives from Latam

From these areas:

  • Biosimilars
  • Biobetters
  • Biotechnology
  • Biotherapeutics
  • Analytical science
  • Regulatory compliance
  • Quality Control
  • Clinical immunology
  • Scientific Affairs
  • Pharmacovigilance
  • Research
  • Regulatory
  • Business Development
  • Marketing

Speaker Board

Program at a Glance

The Benefits of COFEPRIS' New Regulatory Certainty Strategy

COFEPRIS is undertaking a strategic initiative to provide regulatory certainty to pharmaceutical companies, enabling them to introduce medical innovations and drive productive development in the Mexican market. The 2022-2030 agenda aims to foster competitiveness, industrial and commercial growth, and ensure access to safe and high-quality healthcare products.

CECMED's Experiences in Biosimilar Registration and Common Points Regarding International Regulations

CECMED, the Cuban Regulatory Agency for Medicines and Medical Devices, has gained valuable experience in registering biosimilars, with 15 approved products in the country. This experience has highlighted commonalities with international regulations. The agency’s insights into the biosimilar registration process and alignment with global standards contribute to the broader understanding of regulatory practices in the field.

How Market Access Differs Significantly from Region to Region: LatAm, USA, Europe and Asia

The 2014 World Health Assembly resolution urges WHO Member States to enhance access to biotherapeutics, ensuring their quality, safety, and efficacy. Despite progress made, including improved availability of biotherapeutics and biosimilars, significant access gaps persist, in some regions more than others. Beyond guideline updates, factors that can hinder market accessibility are similarity, comparability, substitution, pricing and reimbursement.

Contracting for Success: CROs and CDMOs in Biologics Research and Development in Latin America

Contract Manufacturing Organisations (CMOs) and Contract Development and Manufacturing Organisations (CDMOs) are vital in the global pharmaceutical market, but are notably rare in Latin America, while Contract Research Organisations (CROs) are more common.Transitioning from small in-house projects and academic capabilities to a fully professional and validated scenario is a complex task. Competitiveness, encompassing costs of goods, timelines, success rates, and a global approach, remains a key challenge. Moreover, navigating the intellectual property landscape is crucial, as it impacts both the development of biosimilars and the capacity to offer related services. In Mexico and the rest of the region, they offer a promising way to bridge the gap between foreign investors and local infrastructure and demand.

Investment in Biosimilars in Mexico: Incentives, Expectations and Concerns

Mexico possesses abundant resources and great potential for investment, but lags behind when it comes to regulatory clarity, suitable partnerships, and international awareness of its local infrastructure and academia. To attract investors, it is crucial to raise international awareness, incentivise them to explore the advantages of the Mexican market and, in turn, to understand their concerns, interests, and expectations of investors considering Mexico as a viable market for biosimilar initiatives.

Technology for Processes and Single-Use Technologies for Cell and Gene Therapy

As cell and gene therapies transition from research and development to commercialisation, manufacturers face new challenges. The need to expedite the market entry for these transformative therapies introduces a high risk of implementing inefficient workflow processes. Single-use solutions offer productive strategies for scaling up these processes effectively, while simultaneously reducing risks and costs, and the technology can minimise obstacles associated with a batch by replacing it with a new pre-validated system. By adopting these innovative methods for in-process sampling, manufacturers can significantly enhance workflow efficiency and effectiveness.

Unlocking Regulatory Clarity: COFEPRIS's Latest Strategy Unveiled

With Mexico’s New Regulatory Certainty Strategy and other regulatory developments in the LatAm region, there are new considerations to explore. The importance of harmonising regulatory approaches with other agencies, the role of the public, private and social sectors, and compliance with ICH guidelines are among the factors that have been taken into account when preparing this new strategy. Its impact will play a crucial role in fostering the widespread adoption of biosimilars throughout Latin America.

Full Programme in the PDF Agenda

Download Agenda


Thermo Fisher

Thermo Fisher Scientific is the world leader in serving science. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivitin their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.


We are a vibrant science and technology company. Science is at the heart of everything we do, it drives the discoveries we make and the technologies we create. For more than 350 years, curiosity has been driving us to deliver excellence to patients and customers – and to imagine the future.


As Part of Terumo Medical Care Solutions, the Pharmaceutical Solutions Division develops patient-oriented parenteral delivery solutions for therapeutic performance and safety.

Globally trusted for quality and precision, we offer pharmaceutical and medical device manufacturers around the world comprehensive product design and development services.

We have decades of experience collaborating with pharmaceutical companies from the earliest phases of drug development to product commercialization to optimize critical aspects of parenteral drug delivery.

Innovation and creativity are central to our value proposition. Our expert teams lead the industry in developing and manufacturing advanced, high-performing infusion and injection technologies, including CDMO services for all parenteral applications.

We listen. We question. We deliver. 


With 60+ dedicated scientists and support personal, UDIBI is a third-party laboratory authorized by the Mexican Regulatory Agency (COFEPRIS) to conduct analytical services for the pharmaceutical and medical devices industries. We also provide consulting services on antibody engineering and development of antibody-based therapeutics. With the support from government and private investment we have developed a portfolio of biotherapeutics that includes a product in the market and several therapeutic antibodies in diverse phases of discovery, optimization and preclinical development. In response to COVID-19 pandemic, UDIBI developed and commercializes the only 100% Mexican diagnostic kit to detect anti-SARS-CoV-2 antibodies with approval by COFEPRIS for commercialization in Mexico.

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