COVID-19 Notice

In the current context of the global health crisis, like you, we are committed to acting for health prevention and citizens’ care, and everyone’s safety is our priority.

We remain very attentive to the developments in the situation, in particular those on the rules and instructions relating to gatherings such as our international event BioTech Pharma Summit.
In this very special period, you can always count on our commitment to support you in the best conditions to prepare for the upcoming edition of BioTech Pharma Summit.

During the movement and gathering behaviour restriction, our teams are teleworking at home in order to ensure our service continuity, while ensuring everyone’s safety. We therefore remain available and reachable by e-mail only.

We thank you for your understanding and consideration, and we sincerely hope to welcome you to the next edition of BioTech Pharma Summit on September 27 and 28, 2021 in Porto, Portugal.

In these difficult and uncertain times, our thoughts are with you and all medical and nursing staff.
Let’s take care of each other

The BioTech Pharma Summit team

Connecting
Leaders

EPM Group events are carefully designed to answer critical aspects of business development and followed by in-depth research analysis that complies with the current market and business leaders’ needs. The goal of our events is to implement new strategies and increase your experience and professional skills by networking, benchmarking and generating insights from industry leaders.

New trends, Innovations, Modern technologies, New products, Emerging topics are generated for senior level executives to provide a cutting edge of business information and maximum return of investment for our clients from different areas on the Pharmaceutical industry.

Our team of professionals and experts provides information focused on business strategies that will encourage the competitive advantage of our clients at which they achieve their objectives. EPM team maintains the highest standards of quality and service in research, technology and product development.

A Global BioTech Event that can't be missed!

8 STREAMS | 5000+ Attendees | 1000+ Industry Experts | 200+ Speakers | A lot of networking opportunities

Choose your stream

STREAM #1

Antibody Engineering & Therapeutics

Description

The Antibody Engineering & Therapeutics will provide the latest science, technology and partners to accelerate antibody & protein therapies, ADCS, Bispecifics and Immuno-Oncology.

The global next-generation antibody therapeutics market size was valued at USD 3.83 billion in 2019. This figure is expected to grow at a CAGR of 13% and will reach USD 7.06 billion by 2024.

The next-generation antobody therapeutic is majorly driven by the development of monoclonal antibodies and frowing chronic diseases prevalence. The increasing population, urbanization, and changing lifestyle are favouring the anti-generation antibody therapeutics market growth. Increasing government supports through investments and focus of the pharmaceutical & biotechnology firms on the development of antibodies for future usage of chronic disease are further accelarating the next generation therapeutic market.

The increasing development in the ADCs technology and collaboration are raised the market growth of the next generation antibody therapeutics market. The techologies such as artificial intelligence in the form of software it can lead the product innovation with effective result drive the market

The Summit will shed light on the progress in discovery, development and therapeutics of novel protein therapeutics, and the latest breakthrough engineering next-generation antibody formats. The conference offers a unique opportunity to reach the pre-eminent researchers working in his important field of science from both the industry and academic sectors.

Register now for the Antibody Engineering & Therapeutics event

This event brings you the latest antibody science, technologies and partners needed to accelerate next-generation antibodies towards commercial success.

Key Practical learning Points

  • Bioinformatics and Repertoires in Antibody Discovery and Development
  • Antibody Discovery and Developability
  • Intractable Targets/ Antibody Discovery Technologies
  • Novel Antibody-based Therapeutics for Cancer & Immuno-oncology
  • Antibody Effector Functions and Novel Formats
  • New Antibody Therapeutics in Inflammatory & Infectious Diseases
  • Antibodies Alternative Delivery/Vaccines
  • CAR-T & anti-CD3-based Bispecifics
  • The Nuts and Bolts of Antibodies
  • CMC strategies for developing manufacturing processes and product quality characterization of bispecifics / multispecifics
  • Emerging approaches, science and tech to engineer and to bring to market more targeted, stable extended half-life, and functional multispecifics
  • Advanced analytical development and characterization for novel protein formats
  • Imaging, theranostic, and other new applications of bispecifics in oncology and beyond
  • Accelerating translation and clinical development progress of bispecific antibody and combination therapies
  • Turning Antibody Leads into Drugs
  • Antibody Selection and Screening in Early Discovery
  • Antibody Binding Sites as Therapeutics: scFv, VHH, VNAR and beyond
  • Transforming Therapeutics Targets
  • Developments in ADC Tecnhology
  • Inducible Activation of Antibodies to Enhance Therapeutic Index
  • Responding to the COVID-19 Pandemic with Antibodies, Small Molecules Drugs and Vaccines
  • Sourcing Disease-specific Human Antibodies from Patient Repertoires.
  • Antibody Therapeutics for Autoimmune and Neurodegenerative Diseases
  • Expressing Antibodies by Gene Therapy and/or Viral Therapies
  • Bispecific Formats for T Cell Activation
  • Novel Insights into Immunoglobulin Structures
  • Computational Modeling of Anibody-Antigen Interations
  • FcR and Antibody Effector Functions
  • Novel non-Cancer Targets for Therapeutics Antibodies.
  • Modifying Fc Interactions to Enhance Antibody Therapies.
  • Potentiating Antibodies through Conjugation

Who Should Attend?

  • Antibody Discovery
  • Analytical & Formulation
  • Bioassay
  • Biologics
  • Cancer
  • CD3
  • Clinical trials / Development
  • Central Nervous System (CNS) / Neuroscience
  • Drug Development
  • EGFR
  • Fc
  • Genetics
  • Immunogenicity
  • In Silico Modelling / Quantitative Science
  • Ex Vivo Assay
  • FIH
  • Process Development / Developability
  • Protein Chemistry
  • T-cell
  • Theranostics
  • Toxicities / Toxicology
  • Yield
  • Antibody Engineering
  • Blood Brain Barrier
  • Biochemistry
  • Bispecifics
  • Cancer Immunotherapies
  • Checkpoint
  • CMC / Regulatory
  • Combination Therapies
  • Drug Targets / Targets Selection
  • Preclinical Models
  • Imaging
  • Immunology
  • Mab
  • Monoclonal Antibodies
  • Neuroscience
  • Pharmacokinetics (PK)
  • Process / Manufacturing Quality
  • Protein
  • Screening / Modelling
  • Target Toxities
  • Therapeutic Antibodies
  • Tumours
  • Manufacturing
  • Multispecific Antibody
  • Oncology

STREAM #2

Inhalation & Respiratory Drug Delivery

Description

The IRDD Stream is designed for senior industry experts that will showcase new trends in aerosol science and the future directions of inhalation drug delivery research. Further discussion focusses on the regulatory pathways for inhaled therapies and challenges of bringing respiratory products to market. The agenda also features key case studies on the latest trends in inhalation devices, from inhaled insulin to gene therapy.

A recent report from the Pharmaceutical Research and Manufacturers of America (PhRMA) found America’s biopharmaceutical companies are developing about 130 new medicines for the millions of patients affected by respiratory diseases: chronic obstructive pulmonary disease (COPD), cystic fibrosis, pneumonia, and asthma. These medicines represent critical advancements in respiratory care and improving quality of life. In addition to the drugs, devices delivering those products are being designed to improve the quality of life for an aging population, children, and those who tend not to comply to dosing regimens because they don’t know how to use the device. The global respiratory care devices market is expected to exceed more than $24 billion by 2022,2 and could exceed $33 billion by 2023.

This stream will focus on the challenges of bringing respiratory products to market and innovative aerosol science, including modelling and toxicology. Presentations will also feature key case studies on the latest trends in inhalation devices, from inhaled insulin to gene therapy to overcome lung and pulmonary conditions, such as COPD, asthma and cystic fibrosis. The event highlights some of the innovators and innovations in the respiratory sector, addresses the importance of end users in the device development process, and presents recent advancements in improving patient adherence.

Register now for the IRDD event in Porto

Over 20+ presentations and case studies focused on the key issues in inhalation and respiratory drug delivery.

Key Practical learning Points

  • Novel technologies for pulmonary & nasal delivery
  • Modern respiratory medicines
  • Innovative development of inhalation devices
  • Digital health combination products
  • Analytical tools for inhaled medicines
  • Challenges of bringing inhalation and respiratory drug delivery products to market
  • Regulatory updates in the global respiratory market
  • The challenges of developing inhalation devices
  • Alternative therapeutic fields
  • Innovation in nebulised therapy
  • Triple inhaler therapy in COPD
  • Inhaled drugs through functional respiratory imaging (FRI) and artificial intelligence (AI)
  • Dry-powder inhalers (DPIs) and Metered-dose inhalers (MDIs)
  • New analytical insights into dry powder formulations for inhalation
  • Routes to controlling aerosol response
  • Characterizing aerosol dynamics
  • Model validation
  • Future directions in inhalation and respiratory drug delivery research
  • Regulatory pathways for inhaled therapies
  • Strategies for Managing the Impact of Brexit
  • Challenges of developing a generic inhaled product
  • Explore opportunities with smart and digital inhalers

Who Should Attend?

  • Respiratory Drug Development
  • Generics & Respiratory
  • Inhalation Drug Delivery Technologies
  • Device Development and Engineering
  • Respiratory Pharmacology
  • Medical Devices & Injectors
  • Inhalation Device Development
  • Inhaled Formulation Science
  • Inhalation Product Development
  • Respiratory Regulations
  • Generics & Respiratory
  • Inhalation Process Development
  • Respiratory Medicine
  • Inhalation Drug Delivery
  • E-Health
  • Inhaled Dosage Forms
  • Outsourcing
  • Process Development
  • Respiratory Pharmacology
  • Device Engineering
  • Drug Delivery Innovation
  • Inhalation Devices
  • Metered Dose Inhaler Development
  • Medical Marketing
  • Respiratory R&D
  • Particle Characterisation
  • Business Development
  • New Delivery Technologies
  • Connective Health
  • Respiratory Regulations
  • Pulmonary Disease
  • Inhalation
  • Scientific Research

Slide FEATURED Michael Castagna Michael Castagna is Chief Executive Officer and serves on the Board of Directors for MannKind Corporation. Dr. Castagna has over 20 years of experience in healthcare, pharmaceutical, biotech and specialty pharmacy industries. CHIEF EXECUTIVE OFFICER AT MANNKIND CORPORATION Slide FEATURED Francesca
Buttini
Dr. Francesca Buttini is Associate Professor at the Food and Drug Department, University of Parma (IT) where she is leading the unit dedicated to design of pharmaceutical products for inhalation. She has published more than 60 research papers. ASSOCIATE PROFESSOR AT UNIVERSITY OF PARMA, ITALY
Slide FEATURED Jan De Backer Dr. Jan De Backer graduated from Delft University of Technology, The Netherlands as aerospace engineer. He attained an MSc degree in aerodynamics and specialised in applied biomedical computational fluid dynamics leading to a PhD from the University of Antwerp, Belgium. CHIEF EXECUTIVE OFFICER AT FLUIDDA Slide FEATURED Tonya
Winders
Tonya Winders. MBA is currently the President and Chief Executive Officer of Allergy & Asthma Network, the leading patient advocacy organization dedicated to ending the needless death and suffering due to asthma, allergies and related conditions. PRESIDENT AND CEO AT ALLERGY & ASTHMA NETWORK
Slide FEATURED Mark
Milton-Edwards
Mark is responsible for the Product & Health Solutions within Digital Health at TEVA Pharmaceuticals. Over ten years with TEVA and prior to that sixteen with AstraZeneca. Mark has held various positions including R&D Project Leader, VP Sales & Marketing, Strategic Planning & BD and Global Brand Lead. HEAD OF PRODUCT & HEALTH SOLUTIONS AT TEVA
View all speakers

STREAM #3

Pharmacovigilance & Drug Safety

Description

The Pharmacovigilance & Drug Safety event is designed to bring you a unique opportunity to gain fresh insights into the common issues faced in the industry, highlighting the areas with the need to focus on in order to remain compliant. Moreover this conference stream will bring-forth the participants and the representatives from various fields of pharmacovigilance and drug safety under a common umbrella, and will provide them an opportunity to network with various industry professionals including pharmaceuticals, biologics, devices, CROs and PV service providers.

With the augmented incidence of diseases, and the non-medical use of prescription drugs, the incidence of drug abuse has increased enormously in the recent years, which is apparent with the excess documentation of adversities and drug toxicities. In this context, the drug safety and pharmacovigilance has emerged as a dynamic clinical and scientific discipline to provide adequate information and ensure health safety by the joint interaction of doctors and patients in choosing appropriate treatment method and drug.

Pharmacovigilance & Drug Safety event will give you the foundation for strong strategic planning and practical decision-making in your pharmacovigilance programs, rather than the cookbook approaches often presented elsewhere. In addition to new developments and updates on regional regulations and guidelines, regulators from the US, EU, and other global regions provide the context and thinking behind evolving requirements. The summit will provide a platform for the participants to discuss, share and stay updated with present state of affairs in Pharmacovigilance and Drug safety, and contribute to the public health. It will also allow all its participants to interact with the experts, discuss the various developments, challenges faced and innovations in the field.

Register now for the Pharmacovigilance & Drug Safety Event

We will bring together top professionals working on the latest trends to be both proactive and predictive in PV and drug safety in Europe as well as developing countries.

Key Practical learning Points

  • Impacts of PV on Covid-19
  • Improving Signal surveillance
  • Artificial Intelligence in Signal Detection
  • Combination products – Regulation, trials, and risk management
  • The role of data mining in Pharmacovigilance and its benefits
  • IDMP standards and strategy
  • Developing a pharmacovigilance risk management plan with a risk minimization action plan (RiskMAP) for high risk products
  • Understanding how Artificial Intelligence is transforming pharmacovigilance
  • Evaluation of quality and manufacturing in production
  • Audits and Inspections
  • Strengthening Pharmacovigilance quality management system
  • Impact of AI in Pharmacovigilance
  • Upcoming regulatory changes
  • Signal management
  • Application of data analytics in Pharmacovigilance processes to increase speed of signal detection
  • Cooperation for patients safety
  • Development and deployment of advanced data management systems
  • Does AI have a real role to play in PV?
  • The role of surveys in controlling the overall risk management system
  • Proactive vs. predictive technologies in the future of PV
  • Brexit and the impact on pharmacovigilance
  • Strategies to improve PV
  • Real World Evidence in PV
  • Best practices for developing an overall PV audit strategy with a business partner
  • Is there a way to effectively and reliably use social media towards a QPPV’s end goals?
  • Real-time drug safety data analysis in medical monitoring
  • How has inspection preparation changed and what are the new methods on the horizon?
  • Big data and AI in pharmacovigilance
  • Pharmacovigilance Monitoring and automation in Social media

Who Should Attend?

  • QPPV
  • Risk Management
  • Pharmacoepidemiology
  • Signal Detection
  • Pharmacovigilance
  • Risk Assessment
  • Market Research Programs
  • PV Governance
  • Phase IV/Postmarketing Safety
  • Drug Safety
  • Patient Safety
  • Medical Affairs
  • Quality Assurance
  • Regulatory Affairs
  • Audit Readiness
  • Medical Safety
  • Safety Surveillance

STREAM #4

Pre-filled Syringes & Injectables

Description

The Pre-Filled Syringes conference will bring together all specialists in medical devices and pharmaceuticals to share experience about new technology trends, design considerations, technical developments of quality and materials in pre-filled syringes. The conference will provide a comprehensive overview for market participants to overcome common industry hurdles and gain knowledge in key areas surrounding chemical compatibility, E&L; needle safety; human factors and home-based administration and compliance.

The global market revenue fo prefilled syringes grossed $4.9bn (€4.4bn) in 2018 and is estimated to exceed $9.7bn by 2025. The market driver of the highest stature for the global prefilled syringes market growth is the increase in chronic ailments and demand for advanced medical facilities. The rise in diabetes, cancer, and cardiovascular disorders is also causing market growth. Other important market drivers are increasing research & development (R&D), demand for convenient drug delivery methods, elimination of dosing errors, need for more effective methods for unit dose medication, greater dose precision, suitability for home use, and initiatives from different governments around the world to boost healthcare sector.

The Pre-Filled Syringes & Injectables event will explore the advancements in regulatory guidelines, product development, manufacturing processes, risk mitigation, portfolio management and answer some infinite industry questions such as; how the industry is responding to disruptive technology, connectivity, speed to market, and next generation syringes.

Register now for the Pre-Filled Syringes & Injectables Event

Join us at the Pre-Filled Syringes & Injectables event to share and benchmark against best practices to ensure optimal development in all aspects of pre-filled syringe production.

Key Practical learning Points

  • Current market developments, trends, and needs for Pre-Filled Syringes (PFS)
  • The latest technologies in materials and production process development
  • Navigating regulatory considerations in the PFS market environment
  • New drug formulation strategies
  • Syringe filling of high-concentration monocolonal antibody formulation
  • Human factor and usability engineering for patient-centric
  • Drug-device combination products development challenges
  • Safety evaluation of leachables when developing a pre-filled syringe drug product
  • Next generation design and materials for PFS
  • Challenges of platformization
  • Combination products and auto injectors
  • Technical developments to enhance device quality
  • Sterile manufacturing
  • Ensuring efficient drug development
  • Human-factors engineering and usability
  • Patient centric design considerations for PFS
  • Overview of the upcoming EU MDR regulation, the role of notified bodies
  • The Impact of 21 CFR 4 on design control
  • Patient-Centric dosage form design
  • Digitalization
  • Integrating Quality Requirements
  • Implementation of novel technologies
  • Manufacturing of sterile injectable drugs
  • Analytical studies and chemical safety assessment
  • Smart labeling solutions for pre-filled syringes

Who Should Attend?

  • Bioprocess Research and Development
  • Business Development
  • CMC
  • Combination Products
  • Container Development
  • Controls and Robotics
  • Device Development & Manufacturing
  • Device Engineering & Design
  • Drug Delivery & Devices
  • Formulation Sciences
  • Research and Development
  • Risk Management
  • Stability
  • Standardisation science
  • Sterile Products
  • Vaccines
  • Validation
  • Extractables & Leachables
  • Fill/Finish
  • External Supply
  • Human Factors
  • Injectables
  • Materials Development
  • Medical & Connected Devices
  • Parenterals
  • PFS
  • QA/QC
  • Regulatory AffairsDrug Development
  • Drug Packaging

STREAM #5

Gut-Brain Axis

Description

The Gut-Brain Axis event, brings together leading scientists, physicians, and senior leaders to explore the potential insights into the Microbiota–Gut–Brain Axis, the Human Microbiome Market that exhibits significant potential in the near future.

The ability of gut microbiota to communicate with the brain is emerging as an exciting concept in health and disease. Mounting evidence, mostly from rodent studies, suggests that gut microbes help shape normal neural development, brain biochemistry, and behaviour.

The Gut-Brain Axis will be dedicated to help large pharma, biotech, academics and clinicians exploring and understand the Human Microbiome Market, GBA in demonstrating disease causation. Over the last decade, the microbiome has become one of the trendiest areas of biology, and the research has made clear that the microbiome is fundamental to overall health.

Register now for the Gut-Brain Axis Event

The Gut-Brain Axis event is set to be the “must-attend” meeting for anyone interested in unlocking the potential of the Human Microbiome, and translating it into safe, effective and commercially viable therapeutics.

Key Practical learning Points

  • The influence of the intestinal microbiome on vaccine responses
  • Effectively understand and manipulate the Gut-Brain Axis
  • Learn about the microbiota and their metabolites and neurotransmitters production
  • Influence of the microbiota on vaccine effectiveness
  • Discover tools and technologies to help investigate the GBA
  • Build predictive pre-clinical models in the gut-brain axis
  • The importance of the gut–brain axis in emotional, behavioral and development disorders
  • Stress related bowel disease: gut-brain axis in IBD and IBS
  • Develop commercially viable therapeutics and nutritional products
  • Probiotics, prebiotics, synbiotics and psychobiotics

Who Should Attend?

  • Scientific Project Leader
  • Head Search & Evaluation Neuroscience
  • Molecular Toxicology
  • Nutrition & Health
  • Laboratory Director
  • Neuroscientist
  • Regulatory Affairs
  • Modeling and Data Specialist
  • Microbiome and Lipid Biology
  • Genome Editing
  • Business Develoment
  • Associate Research Director
  • Strategy & Business
  • IVD Assay Development
  • Safety Risk Lead
  • Skin & Health
  • Preclinical Group Leader
  • Pharmacovigilance
  • Drug Discovery
  • Research Investigator

STREAM #6

Probiotics, Human & Skin Microbiome

Description

The Probiotics, Human & Skin Microbiome event, brings together leading scientists, physicians, and senior leaders to explore the potential insights into the Probiotics, Human & Skin Microbiome that exhibits significant potential in the near future. The event will showcase Industry Case Studies and regulatory insights of the skin microbiome and its impact on cutaneous structure in healthy, aged and compromised state as well as integrated approaches that has been used in human gut microbiome research.

Probiotics as a key functional ingredient in targeting major skin concerns (acne, blemishes, wrinkles etc) is gaining popularity in research, with increasing clinical evidence pointing towards their efficacy. Probiotics – products containing live bacteria – comprise of only a small portion of commercialized cosmetic products and hold great untapped potential in the skincare market. However, implementing live bacteria into mainstream products is not easy. Bacterial products require aseptic conditions, a challenge for packaging, and often have a short shelf life so do not last long.

The current skin microbiome market is dominated by Western countries, with Europe and US being the two largest consumers of cosmetics, but the Asian and Latin American regions are rapidly growing, and a shift is expected within the coming years. The growth of the market only emphasises the huge opportunities for companies working in the skin microbiome space.

This year’s agenda will aim to examine the latest scientific, technological and commercialisation trends in the industry. Presentations will cover topics such as skin health, wellbeing and skin microbiome- associated disease, emerging technologies in the skin microbiome field and cosmetic versus therapeutic regulatory considerations. Don't miss the opportunity to join leading industry experts to explore next steps for skin microbiome research and development, as well as commercialization.

Register now for the Probiotics, Human & Skin Microbiome Event

Access 20+ presentations to discover more about the latest scientific, technological and commercialisation trends and learn how they are driving forward.

Key Practical learning Points

  • Skin Disease & Microbiome
  • The impact of environment and age on shaping our individual microbiota
  • The skin microbiome: Current perspectives and future challenges
  • Preservative Free-Formulation, Manufacturing and Packing
  • The Skin Microbiome & Big Data
  • Metabolites & Skin Microbiome
  • The Development and Maintenance of the Skin Barrier
  • Learn from research applied to atopic dermatitis, seborrheic dermatitis, fungal-associated diseases and co-infecting microbes that promote chronic wound infection
  • Build on existing partnerships and create new collaborations across industry & academia
  • Commercialization of Microbiome-Based Personal Care
  • Human Skin Microbiome: From metagenomes to therapeutics
  • Regulation considerations for dermatology & cosmetics
  • The applications of L. reuteri DSM 17938 in skin health
  • Commercialising the Therapeutic Potential of The Microbiome in the Field of Metabolic Diseases
  • Discover the latest research into commensal fungi of the mammalian skin
  • Assess the role of the human skin microbiome in precision health
  • Get the latest insights on successful strategies to commercialise Skin Microbiome Research
  • Discover how electrogenic skin bacteria will become novel probiotics for treatments of human diseases
  • Explore a radical shift in the beauty industry, which is seeking to be increasingly pro-bacterial

Who Should Attend?

  • Scientific Project Leader
  • Academic Researchers
  • Molecular Toxicology
  • Nutrition & Health
  • Laboratory Director
  • Independent Beauty Brands
  • Regulatory Affairs
  • Modeling and Data Specialist
  • Microbiome and Lipid Biology
  • Genome Editing
  • Business Develoment
  • Associate Research Director
  • Strategy & Business
  • Dermatologists
  • Safety Risk Lead
  • Skin & Health
  • Preclinical Group Leader
  • Cosmetic Formulators
  • Ingredients Suppliers
  • Research Investigator
  • Packaging Manufacturers

STREAM #7

Aseptic Processing Technology

Description

Aseptic Processing Technology event will overview regulatory updates and their implementation, main challenges and overcome consideration, new technologies and innovations to avoid mistakes and ensure safe highly potent aseptic production for both sides - manufacturer and patient. This event will help you improve your aseptic processes and address contamination control issues that you may encounter.

The aseptic processing industry has seen many changes during its progression towards the 21st century. With advances in innovative therapeutic manufacturing such as ATMPs, pragmatic barrier system applications, adaptability and modularity in fill finish, robotics and automation, small and agile product manufacturing, just to name a few. In 2018, the global aseptic processing market was valued over $56 trillion and is estimated to increase in net revenue upwards $124 trillion by 2027, with a CAGR growth of 9.18%.

At the event you will have the opportunity to discourse and to network with peers involved in pharmaceutical manufacturing, aseptic fill and finish, quality control, engineering, and container development. Key topics in Aseptic Processing will be discussed by some of the industry’s leading lights.

During this event, you will learn about environmental monitoring systems, facility cleaning and disinfectant qualification, aseptic cleanroom operations, filtration, sterilization, aseptic process simulation, and regulatory requirements. Hands-on activities will include gowning qualification, facility cleaning and disinfection, aseptic technique qualification, aseptic process simulation, and microbial identification.

Register now for the Aseptic Processing Technology Event

Join us to explore novel and developing technologies that tackle the most pressing challenges and push innovation in the world of aseptic processing and sterile manufacturing.

Key Practical learning Points

  • The Evolution of Aseptic Technologies
  • Multi-Product facilities
  • Regulatory framework. Aseptic Processing principles.
  • Antibody Drug Conjugates / HPAPIs production
  • Lyophilization of highly potent products and aseptic processing.
  • Occupational safety requirements
  • Aseptic process development, validation and evaluation.
  • Aseptic processing simulation
  • Highly potent facility design and engineering considerations
  • Isolator Technology use in aseptic processing for loss minimization/elimination.
  • Overcoming technical challenges in decontamination processes and material transfers.
  • Cleaning and disinfection programs for aseptic facilities.
  • Microbiology concepts and techniques
  • Cross contamination prevention and control for highly potent products.
  • Robotics in aseptic processing
  • Gloveless Isolators and dose control
  • Final fill with SU Equipment
  • ADC/HPAPI aseptic processing fill and finish
  • Challenges for manufacturers in cell and gene therapy production systems
  • Airflow visualization for contamination risks assessment.
  • Implementing containment technologies in aseptic processing
  • Boosting sterilization: successful strategies, advanced technologies implementation.
  • Cleaning automation and technologies.
  • Gowning: procedures, training, personnel qualification.
  • Microbiology techniques use in aseptic processing.
  • Integrating sanitization techniques to empower contamination control.
  • Filtration: filter integrity testing in aseptic processing.
  • Single-use systems implementation.
  • Assess airflow visualization to limit risk for product contamination
  • Describe the importance of filter integrity testing for aseptic operations
  • Cleanrooms for the Annex 1 updates
  • Implementation of quality risk management

Who Should Attend?

  • Bioprocess Research
  • and Development
  • Biotechnology
  • Container Development
  • CMC
  • Drug Development
  • Engineering
  • Fill and Finish
  • Freeze-Drying
  • Formulation
  • Medical Devices
  • Nanomaterials
  • Parenterals
  • Packaging and Labelling
  • Pharmaceutical Process and Technology
  • Process Monitoring and Control
  • Process Analytics
  • Product Innovation
  • Packaging
  • QA/QC
  • R&D
  • Risk Management
  • Regulatory Affairs
  • Stability
  • Standardisation Science
  • Sterilisation
  • Vaccine/Antibody/Cell Manufacturing
  • Validation
  • Licensing
  • Lyophilisation

STREAM #8

Drug/Device Combination Products

Description

The Drug/Device Combination Products event will examine the current US and global regulatory environments for combination product development and approval, including new FDA regulation and guidances, and late-breaking information on implementation of the EU Medical Device Regulation. This event will provide a better understanding of both regulatory and practical aspects of developing drug-device combinations, as well as the management of combination products across the total product life cycle.

The global drug-device combination products market was valued at $81,374 million in 2017 and is projected to reach $139,193 million by 2025 at a CAGR of 6.9% from 2018 to 2025. The growth of the Global Drug-device Combination Products Market is driven by rise in incidence of chronic diseases such as diabetes, cancer, and respiratory problems, increase in casualties owing to accidents and trauma, rise in geriatric population, growth in home-based healthcare market, and technological advancements such as development of prefilled syringes. However, factors, such as unnoticed complications of drug-device combination products, number of product recalls, and stringent government regulations, hamper the market growth. Conversely, rise in healthcare infrastructure and high market potential in untapped emerging economies are expected to provide lucrative growth opportunities for the market.

Combination products bring together generic or biologic drug and medical devices to more effectively deliver treatments to patients. They are still relatively new delivery systems for the healthcare market. During the past few years new regulations and legal developments have improved the framework for combination product development and evolved the technology. Therefore that process increased technological requirements, as well as quality systems and lifecycle management.

Register now for the Drug/Device Combination Products Event

Drug/device combination products present unique challenges. Under EU law, combination products must be registered as either pharmaceutical products or medical devices. Find useful insights into requirements for devices to improve your understanding of additional aspects to be incorporated into your dossier.

Key Practical learning Points

  • Development of Combination Products from Initial Studies Through Post Market Management
  • EU MDR Compliance for Commercial Combination Products
  • Regulatory Pathways and Control Strategies
  • Life Cycle Management and Platforming
  • Implication for Combination Products
  • Digitalization Trend in Combination Product Use and Design
  • Approach and Strategy in Developing Drug/Biologic/Device Combination Products
  • Wearable Devices in Drug Delivery and Combination Product Development
  • Application and Characterization of Biodegradable Polymers as a Drug Delivery Conduit in Combination Products
  • Application of Mathematical Modelling in Design and Validation of Drug/Biologic/Device Combination Products
  • Real World Challenges for a Pharmaceutical Organization
  • A System-Wide Approach to Stability of Combination Products
  • Translation of User Research to Actionable Product Specification
  • Integrated Development and Risk Management Process for Combination Products
  • Driving innovations to extend your combination product lifespan.
  • Connected digital technologies and next generation combination products.
  • FDA Considerations for Speedy Product Approval & Continued Compliance
  • Impact Of International Market Challenges Including EU MDR
  • Practices to demonstrate design control compliance
  • Key clinical study design considerations for connected combination products including unique endpoints and instrumenting for RWE collection
  • Describe challenges and opportunities in lifecycle management programs for complex Combination Advanced Therapeutic Medical Products (CATMPs)
  • Registering DDC products across the globe.
  • LCM strategies and regulatory considerations.
  • Platform selecting and engaging the right stakeholders in the product development process.
  • Addressing the differences and gaps between drug and device development plans.
  • Streamlining a quality management system to support sustainable LCM.
  • Identifying essential performance requirements and associated control strategies.
  • Integration of design control throughout LCM. Design verification and process validation.
  • Risk-based approaches to design and development of drug delivery systems.
  • Utilizing human factors in combination products risk management.
  • Clinical evaluation for combination products.
  • Drug/device compatibility, safety evaluation and testing for combination products.
  • Best practices for post approval changes.
  • Assessing post market surveillance to support effective lifecycle management.

Who Should Attend?

  • CMC
  • Compliance
  • Design Controls
  • Device Development & Manufacturing
  • Drug Delivery & Devices
  • Human Factors
  • Packaging
  • Risk Management
  • eClinical
  • Regulatory Operations
  • Research and Development
  • Submissions
  • Combination Products
  • Controls & Robotics
  • Device Design
  • Device Engineering & Design
  • Formulation Sciences
  • Pre-filled Syringes
  • Quality Assurance / Control
  • Validation
  • Consulting
  • Legal, Government Affairs
  • Quality Assurance and Control
  • Clinical Research
  • Research & Development
  • Usability Engineering
  • Inhalation Products
  • Parenteral Products
  • Product Quality
  • Regulatory Affairs
  • Biopharmaceutical
  • Generics, Biosimilars, Device, and Combination Product R&D and Development
  • Business Development
  • Policy