Regulatory Services

The ESMO Congress is the yearly appointment in Europe for nearly 30,000 clinicians, researchers, oncology nurses, patient advocates, journalists, and representatives of the pharmaceutical industry from all over the world to get together, learn about the latest advances in oncology, and translate science into better cancer patient care. Medical/clinical oncologists, basic translational researchers, oncology nurses, all other oncology professionals, patient advocates, journalists, healthcare industry representatives, policy decision makers, regulators.

The Global Clinical Trials Connect 2023 will provide a platform to discuss on the futuristic advancements in clinical trials and clinical research. This multidisciplinary program involves broad participation of people from clinical trials community from around the globe who are focused on learning more about clinical research, clinical trials planning and management.

Hundreds of clinical trials using AAV are underway, with several hundred more in preclinical development. Given the sheer volume of studies in the pipeline, the need to administer high doses, the clinical holds placed on gene therapy trials, and regulatory bodies being increasingly stringent on the safety standards they require; it has never been more important to create and implement an AAV safety strategy that’s fit for purpose! In this setting, the inaugural Optimizing AAV Safety Summit is bringing together key leaders focussed specifically on solving AAV safety challenges across toxicology, pharmacology, non-clinical study leads, clinical development safety specialists and bioanalysis innovators to gain insights on optimizing AAV safety processes and benefit-risk analysis to shorten timelines and prevent potential delays.Join us in Boston alongside key biotech and pharma leaders from the likes of Spark Therapeutics, Ask Bio, Eli Lilly, Takeda, and more in the AAV space who are prioritizing the development of safe and effective genetic therapies, learn how clinical safety signals have changed how companies are approaching their pipeline progression, and gain immediately implementable insights to sharpen your programs currently in preclinical and clinical development.

The field of food allergy therapeutics is continuing to boom as companies flood the news with fresh IND clearances and clinical readouts. The race to market for the next food allergy therapy is well and truly on, but access to funding and large patient cohorts, along with the need for novel IgE biomarkers and better diagnostics (to name a few challenges) are holding drug developers back from even faster progress. The 2nd Next-Generation Food Allergy Drug Development Summit is reuniting this December as the only industry-focused meeting dedicated to unveiling the complexities of food allergies with novel oral immunotherapies, antibody-based therapeutics and microbiome-based approaches to accelerate ground-breaking treatments for the ever-increasing unmet medical need.

The CNS Summit has become the premiere event for all those involved in clinical development to meet, network, and participate in initiatives that will shape the future. The summit is a platform for change and a community passionate about shaping the future, with a focus on collaboration, innovation, and technology. The mission is to have a positive impact on the success of clinical development programs. Join the pharma and biotech R&D leaders, the top tech companies involved in clinical development and healthcare innovation, investigator sites, service companies, and the regulators from FDA and EMA.

The Cell & Gene Meeting on the Mesa is the sector’s foremost annual conference bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies. The program features expert-led panels, extensive partnering capabilities, exclusive networking opportunities, and 100+ dedicated presentations by the leading publicly traded and privately held companies in the space. Attracting over 1,700 attendees – over 20% of which are C-level executives – this conference enables key partnerships through more than 3,000 one-on one meetings while highlighting the significant clinical and commercial progress in the field.

The Cell & Gene Meeting on the Mediterranean is the leading conference bringing together the entire cell and gene therapy community from Europe and beyond. Covering a wide range of commercialization topics from market access and regulatory issues to manufacturing and financing the sector, this program features expert-led panels, extensive one-on-one partnering capabilities, exclusive networking opportunities, and 60+ dedicated presentations by leading publicly traded and privately held companies in the space. Join ARM for Europe’s premier conference for advanced therapies.

Whether you are a clinical research novice or veteran, work with a study sponsor, research site or CRO, MAGI will offer best-in-class educational opportunities for all career levels in support of your continuing education and your professional growth and success.

Join clinical 800+ professionals at MAGI’s conference, which includes 100+ sessions and workshops in six tracks that offer practical information on clinical operations & project management, site management, contracts, budgets & billing, regulatory compliance, and special topics. About half of the attendees will have leadership roles like CEO, vice president, or director. About three-quarters will have eight or more years of clinical research experience. Study sponsors will be split about 75% biopharma and 25% medical device. Sites will be almost evenly split between (a) academic medical centers, (b) health systems and community hospitals, and (c) independent sites and clinics.

The European Medicines Agency (EMA) have issued a network strategy to 2025 with the mission: Protecting Public Health at a Time of Rapid Change. The strategic focus areas are availability and accessibility of medicines, data analytics-digital tools and digital transformation, innovation, anti-microbial resistance, other emerging health threats, supply chain challenges, sustainability of the network and operational excellence. This sets the framework for the 2022 ISPE Europe Annual Conference in Madrid in April. High level speakers from the European Commission, the European Federation of Pharmaceutical Industries’ Associations (EFPIA) as well as European National Competent Authorities engaged in sustainability will give input to ISPEs well known traditional Executive Forum. Special focus will feature industry speakers on learnings from the COVID-19 crisis and the management of vaccine production and logistics.