Intelligent Bio Solutions Announces Closing of $10.0 Million Private Placement Priced At-the-Market Under Nasdaq Rules

Intelligent Bio Solutions Announces Closing of $10.0 Million Private Placement Priced At-the-Market Under Nasdaq Rules




Intelligent Bio Solutions Announces Closing of $10.0 Million Private Placement Priced At-the-Market Under Nasdaq Rules

NEW YORK, Jan. 02, 2026 (GLOBE NEWSWIRE) — Intelligent Bio Solutions Inc. (“INBS” or the “Company”) (Nasdaq: INBS), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the closing of its previously announced private placement with two healthcare focused institutional investors priced at-the-market under Nasdaq rules of 2,298,850 shares of common stock (or pre-funded warrants in lieu thereof), Series K-1 warrants to purchase up to an aggregate of 2,298,850 shares of common stock and Series K-2 warrants to purchase up to an aggregate of 2,298,850 shares of common stock, at a combined purchase price of $4.35 per share of common stock (or pre-funded warrant) and associated Series K-1warrants and Series K-2 warrants, for expected gross proceeds to INBS of approximately $10.0 million, before deducting placement agent fees and other offering expenses payable by the Company. The Series K-1warrants and Series K-2 warrants will have an exercise price of $4.10 per share of common stock and will be exercisable immediately upon issuance. The Series K-1 warrants and Series K-2 warrants will each have a term of five years following the date a registration statement registering all warrant shares underlying the Series K-1 warrants and Series K-2 warrants is declared effective by the United States Securities and Exchange Commission (the “SEC”).

Harry Simeonidis, President and CEO of INBS, commented, “We welcome the continued support from our investors as we intend to use the proceeds of this private placement for working capital and general corporate purposes, including funding our 510(k) submission with the FDA for our non-invasive Intelligent Fingerprinting Drug Screening System and furthering our international market expansion.”

Ladenburg Thalmann & Co. Inc. acted as the exclusive placement agent for the private placement.

The offer and sale of the foregoing securities were made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Under an agreement with the investors, the Company agreed to file an initial registration statement with the SEC covering the resale of the shares of common stock issued to the investors (including the shares of common stock issuable upon the exercise of the warrants) no later than 10 calendar days following the date of the agreement and to use its best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 45 days after the date of such agreement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. 

About Intelligent Bio Solutions Inc.

Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering intelligent, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company’s current customer segments outside the U.S. include construction, manufacturing and engineering, transport and logistics firms, mining, drug treatment organizations, and coroners.

For more information, visit: http://www.ibs.inc/.

Forward-Looking Statements:

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, Intelligent Bio Solutions Inc.’s intended use of proceeds from the private placement, ability to develop and commercialize its drug and diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure regulatory approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, included in Intelligent Bio Solutions’ public filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:

Intelligent Bio Solutions Inc.
info@ibs.inc

Investor & Media Contact:

Valter Pinto, Managing Director
KCSA Strategic Communications
PH: (212) 896-1254
INBS@kcsa.com

Regeneron to Report Fourth Quarter and Full Year 2025 Financial and Operating Results and Host Conference Call and Webcast on January 30, 2026

Regeneron to Report Fourth Quarter and Full Year 2025 Financial and Operating Results and Host Conference Call and Webcast on January 30, 2026




Regeneron to Report Fourth Quarter and Full Year 2025 Financial and Operating Results and Host Conference Call and Webcast on January 30, 2026

TARRYTOWN, N.Y., Jan. 02, 2026 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its fourth quarter and full year 2025 financial and operating results on Friday, January 30, 2026, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

Conference Call Information
Participants may access the conference call live via webcast on the ’Investors and Media’ page of Regeneron’s website at https://investor.regeneron.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay and transcript of the conference call and webcast will be archived on the Company’s website for at least 30 days.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. 

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

Contact Information:
Investor Relations Corporate Communications
Ryan Crowe Christina Chan
914.847.8790 914.847.8827
ryan.crowe@regeneron.com christina.chan@regeneron.com

Terns Pharmaceuticals Reports Inducement Grants to New Employees Under Nasdaq Listing Rule 5635(C)(4)

Terns Pharmaceuticals Reports Inducement Grants to New Employees Under Nasdaq Listing Rule 5635(C)(4)




Terns Pharmaceuticals Reports Inducement Grants to New Employees Under Nasdaq Listing Rule 5635(C)(4)

FOSTER CITY, Calif., Jan. 02, 2026 (GLOBE NEWSWIRE) — Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage oncology company, today announced that it has granted as of January 1, 2026 equity inducement awards to two new employees under the terms of the 2022 Employment Inducement Award Plan, as amended. The equity awards were approved by the Compensation Committee of the Company’s Board of Directors in accordance with Nasdaq Listing Rule 5635(c)(4) and were made as a material inducement to the employees’ acceptance of employment with Terns.

The Company granted options to purchase 312,000 shares, in the aggregate, of Terns common stock to the new employees. The options have a 10-year term and an exercise price per share equal to $40.40, which was the closing price of Terns’ common stock on December 31, 2025. The options vest over four years, subject to the employees’ continued service through the applicable vesting dates.

About Terns Pharmaceuticals

Terns Pharmaceuticals is a clinical-stage oncology company reimagining known biology to deliver high impact medicines. Our lead program, TERN-701, is a highly selective, oral, allosteric BCR-ABL inhibitor with a potentially best-in-disease profile that could meaningfully improve upon the efficacy, safety and convenience of existing treatments for chronic myeloid leukemia. For more information, please visit: www.ternspharma.com.

Contacts for Terns

Investors
Justin Ng
investors@ternspharma.com

Media
Jenna Urban
CG Life
media@ternspharma.com

Bausch + Lomb Completes Refinancing of Outstanding Term B Loans

Bausch + Lomb Completes Refinancing of Outstanding Term B Loans




Bausch + Lomb Completes Refinancing of Outstanding Term B Loans

VAUGHAN, Ontario–(BUSINESS WIRE)–Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb” or the “company”), a leading global eye health company dedicated to helping people see better to live better, today announced that it closed the previously announced credit agreement refinancing. In connection with the closing, Bausch + Lomb has entered into a fourth amendment (the “Fourth Amendment”) to its existing credit agreement providing for a $2,802,125,000 tranche (the “Replacement Term Loans”) of new term B loans, the proceeds of which were used to refinance all of its outstanding term B loans due 2031 (the “Third Amendment Term Loans”) and its outstanding term B loans due 2028 (the “First Incremental Term Loans”).


The amortization rate for the Replacement Term Loans is 1.00% per annum and the first installment shall be payable on June 30, 2026. Pursuant to the Fourth Amendment, the applicable margin is (i) 3.75% per annum for Replacement Term Loans with an interest rate determined by reference to term SOFR and (ii) 2.75% per annum for Replacement Term Loans with an interest rate determined by reference to the alternate base rate. The margin applicable to the Replacement Term Loans represents a 0.50% per annum reduction from the applicable margin that applied to the Third Amendment Term Loans and a 0.25% per annum reduction from the applicable margin that applied to the First Incremental Term Loans. The Replacement Term Loans will mature on January 15, 2031, which is the same maturity date that applied to the Third Amendment Term Loans and which represents an effective maturity extension of the First Incremental Term Loans from September 29, 2028.

About Bausch + Lomb

Our mission is simple – we help people see better to live better, all over the world. For nearly two centuries we’ve evolved with the changing needs of patients and customers, and our commitment to innovation and improving the standard of care in eye health has never been stronger. From contact lenses to prescription products, over-the-counter options, surgical devices and more, we’re turning bold ideas into better outcomes through passion, perseverance and purpose. Learn more at www.bausch.com and connect with us on Facebook, Instagram, LinkedIn, X and YouTube.

Forward-looking Statements

This news release may contain forward-looking information and statements within the meaning of applicable securities laws (collectively, “forward-looking statements”). Forward-looking statements may generally be identified by the use of the words “anticipates,” “seeks,” “expects,” “plans,” “should,” “could,” “would,” “may,” “will,” “believes,” “potential,” “pending” or “proposed” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb’s filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators (including the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2024 and its most recent quarterly filings). In addition, certain material factors and assumptions have been applied in making these forward-looking statements, including the assumption that the risks and uncertainties discussed in such filings will not cause actual results or events to differ materially from those described in these forward-looking statements. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

© 2026 Bausch + Lomb.

Contacts

Media Contact:

Chris Clark

chris.clark@bausch.com
(848) 360-1100

Investor Contact:

George Gadkowski

george.gadkowski@bausch.com
(877) 354-3705 (toll free)

(908) 927-0735

Xeris Pharmaceuticals Announces Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Xeris Pharmaceuticals Announces Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)




Xeris Pharmaceuticals Announces Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

CHICAGO–(BUSINESS WIRE)–Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that on January 2, 2026, the Compensation Committee of Xeris’ Board of Directors granted restricted stock units for an aggregate of 181,550 shares of its common stock to 50 new employee(s) under Xeris’ Inducement Equity Plan.


Xeris’ Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously employed by Xeris or one of its subsidiaries as an inducement material to such individual’s entering into employment with Xeris or one of its subsidiaries, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules. The restricted stock units will vest over a period of three years in equal annual installments and are subject to the employees’ continued employment with Xeris or one of its subsidiaries. All equity awards are subject to the terms and conditions of Xeris’ Inducement Equity Plan and forms of award agreements covering the grants.

About Xeris

Xeris (Nasdaq: XERS) is a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products: Recorlev®, for the treatment of endogenous Cushing’s syndrome; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, and a gastrointestinal motility inhibitor when used as a diagnostic aid; and Keveyis®, a proven therapy for primary periodic paralysis. Xeris also has a pipeline of development programs led by XP-8121, a Phase 3-ready, once-weekly subcutaneous injection for hypothyroidism, as well as early-stage programs leveraging Xeris’ technology platforms, XeriSol® and XeriJect®, for its partners.

Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow us on X, LinkedIn, or Instagram.

Contacts

Investor Contact
Allison Wey

Senior Vice President, Investor Relations and Corporate Communications

awey@xerispharma.com

GH Research to Announce IND Status for GH001

GH Research to Announce IND Status for GH001




GH Research to Announce IND Status for GH001

DUBLIN, Jan. 02, 2026 (GLOBE NEWSWIRE) — GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today reported that it will provide an update on the status of its Investigational New Drug Application (IND) for GH001 with the U.S. Food and Drug Administration (FDA) and its global pivotal Phase 3 program in treatment-resistant depression (TRD) on Monday, January 5, 2026, at 7.00 a.m. EST.

About GH Research PLC

GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression. GH Research PLC’s initial focus is on developing its novel and proprietary mebufotenin therapies for the treatment of patients with TRD.

About GH001

Our lead product candidate, GH001, is formulated for mebufotenin administration via a proprietary inhalation approach. Based on the observed clinical activity in our Phase 2b GH001-TRD-201 trial, where the primary endpoint was met with a MADRS reduction from baseline of -15.5 points compared with placebo on Day 8 (p<0.0001), we believe that GH001 has the potential to change the way TRD is treated today.

Investor Relations:
Julie Ryan
GH Research PLC
investors@ghres.com

Protein Engineering for Pharmaceutical Biotechnology Training Course: Understand How to Advance Therapeutic Development and Industrial Applications (Jan 21st – Jan 22nd, 2026) – ResearchAndMarkets.com

Protein Engineering for Pharmaceutical Biotechnology Training Course: Understand How to Advance Therapeutic Development and Industrial Applications (Jan 21st – Jan 22nd, 2026) – ResearchAndMarkets.com




Protein Engineering for Pharmaceutical Biotechnology Training Course: Understand How to Advance Therapeutic Development and Industrial Applications (Jan 21st – Jan 22nd, 2026) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Protein Engineering for Pharmaceutical Biotechnology Training Course (Jan 21st – Jan 22nd, 2026)” training has been added to ResearchAndMarkets.com’s offering.


Enhance your knowledge in protein engineering to understand how to advance therapeutic development and industrial applications.

Protein-based therapeutics have significantly advanced and created new paradigms in disease treatment. Half of the top ten selling drugs in 2023 were protein-based therapeutics.

Protein engineering, a field perfected by nature over billions of years, can now be replicated and customised in the laboratory within weeks. This course aims to equip professionals with the skills to develop more valuable and better-featured proteins, particularly enzymes, for a wide range of pharmaceutical applications.

By understanding and applying the latest advancements in molecular biology, protein chemistry, enzymology, and structural chemistry, attendees will be able to create practical solutions that meet the needs of the pharmaceutical sector. The significance and timelessness of this training are underscored by the 2018 Nobel Prize for Chemistry, awarded for groundbreaking work in protein engineering, highlighting its growing importance and potential to revolutionise various industries.

Benefits of attending

  • Deepen your understanding of protein engineering concepts, enhancing your expertise in molecular biology, protein chemistry and enzymology
  • Stay updated with the latest advancements in protein engineering, including CRISPR-Cas9 gene editing, phage display for protein-protein interactions, and mRNA therapeutics, keeping you at the forefront of the field
  • Explore the development and application of protein-based therapeutics such as bispecific antibodies, antibody fragments, mRNA vaccines, antibody-drug conjugates, and antibody-directed enzyme pro-drug therapy
  • Discover how protein engineering is used in biotechnology, including the development of genetically modified organisms (GMOs), biopharmaceuticals, directed evolution for enzyme production, and industrial enzymes

Who Should Attend:

This course is designed for professionals with a foundational understanding of biochemistry and molecular biology, seeking to deepen their knowledge and understanding in protein engineering, including:

  • Biotechnology professionals
  • Regulatory affairs professionals
  • Pharmaceutical development specialists
  • Quality assurance and control officers
  • Clinical researchers
  • Process development engineers
  • Project managers

Certifications:

  • CPD: 12 hours for your records
  • Certificate of completion

Key Topics Covered:

Day 1

Introduction to protein engineering

  • Definition and Overview: What is Protein engineering?
  • Proteins and their structure-function relationship
  • Historical Background: Milestones in Protein engineering and biotechnology in pharmaceuticals

Techniques and tools in genetic engineering

  • CRISPR-Cas9

    • Mechanisms and applications in gene editing
  • Recombinant DNA Technology

    • How genes are spliced and introduced into host organisms
    • Mutagenesis techniques, site-directed, random mutagenesis
  • Gene cloning

    • Cloning vectors, host organisms, and production of recombinant proteins
  • Gene expression systems

    • Bacterial, yeast, and mammalian cell expression systems for protein production
  • RNA interference (RNAi)

    • Mechanisms and therapeutic use for gene silencing in diseases

Pharmaceutical applications of protein engineering

  • Biopharmaceuticals

    • Production of therapeutic proteins (e.g., insulin, human growth hormone)
    • Monoclonal antibodies (mAbs) for cancer, autoimmune diseases, etc.
  • Gene therapy

    • Correcting genetic disorders by inserting or modifying genes (e.g., treatments for hemophilia, cystic fibrosis)
    • CRISPR-based gene editing for inherited diseases
  • Vaccines

    • Development of recombinant vaccines (e.g., hepatitis B vaccine)
    • mRNA vaccines (e.g., COVID-19 vaccines)

Production of biopharmaceuticals

  • Bioreactors and fermentation

    • Use of genetically engineered microorganisms to produce drugs in large quantities
  • Downstream processing

    • Purification and scaling up of genetically engineered drugs
  • Quality control

    • Ensuring purity, potency, and safety of biopharmaceutical products

Day 2

Ethical and regulatory considerations

  • Ethics of genetic and protein engineering

    • Ethical concerns surrounding genetic modifications in humans, animals, and microorganisms
  • Regulatory frameworks

    • FDA, EMA, and other global regulatory bodies for approving genetically engineered drugs
  • Intellectual property

    • Parenting genetically engineered products and processes

Advances in protein engineering for pharmaceuticals

  • CRISPR-based therapies

    • Engineering proteins for diagnostics
    • Clinical trials and potential cures for genetic diseases
  • Synthetic biology

    • Designing new biological systems for drug production and personalised medicine
  • Personalised medicine

    • Tailoring treatments based on individual genetic profiles
  • Biologics vs. small molecule drugs

    • Differences and advantages of biologics developed through genetic engineering

Challenges in protein engineering for pharmaceuticals

  • Safety Concerns

    • Off-target effects in gene editing and immune responses to engineered proteins
  • Cost and accessibility

    • High production costs and making therapies accessible to a wider population
  • Scalability

    • Challenges in producing genetically engineered drugs on a large scale

Case studies and examples

  • Insulin production

    • How genetically engineered bacteria produce human insulin
  • Gene therapy success stories

    • Examples of successful gene therapies (e.g., Luxturna for inherited retinal disease)
  • Monoclonal antibodies

    • Their role in treating cancers and autoimmune diseases

Engineering modern drugs and targeted cancer therapy

  • Checkpoint inhibitors
  • CAR-T cancer therapy
  • Antibody-drug conjugates (ADC)
  • Antibody Directed ProDrug Therapy (ADEP)

Engineering of superantigens for targeted cancer therapy

For more information about this training visit https://www.researchandmarkets.com/r/oc785t

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Development of Combination Products: 2 Day Critical Interactions Training Course (Feb 9th – Feb 10th, 2026) – ResearchAndMarkets.com

Development of Combination Products: 2 Day Critical Interactions Training Course (Feb 9th – Feb 10th, 2026) – ResearchAndMarkets.com




Development of Combination Products: 2 Day Critical Interactions Training Course (Feb 9th – Feb 10th, 2026) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Development of Combination Products: Critical Interactions Training Course (Feb 9th – Feb 10th, 2026)” training has been added to ResearchAndMarkets.com’s offering.


The programme will cover the regulatory strategy to adopt and the relevant aspects of GMP and quality processes, including the data expectations for the CTD. It will also review the key relationships between quality, regulatory, R&D and production. Delegates will find this a comprehensive overview of the requirements for these products and will have an opportunity to discuss the complexities with an expert in this field.

Drug/device and device/drug combination products are becoming increasingly important in the medical industry. The development and manufacture of these products raises a number of complex issues and the quality and regulatory aspects are challenging. This interactive seminar will clarify the EU and US approach to drug/device and device/drug combination products, address the requirements for the device technical file/design file, explain the biological and synthetic drug regulations and look at the registration procedures for these products.

Benefits of attending:

  • Clarify the definitions for drug/device and device/drug combination products in the EU and USA
  • Consider the requirements for the device technical file/design file
  • Comply with the biological and synthetic drug regulations
  • Understand the registration procedures for devices and medicines in the EU and USA
  • Determine the data required for the Common Technical Document (CTD)
  • Consider the regulatory strategy depending on your product
  • Gain practical advice on how to apply the ISO standards

Who Should Attend:

  • All development, regulatory and quality personnel involved in the development of combination products (drug/device and device/drug products)
  • Pharmacovigilance/vigilance personnel
  • Device experts looking to expand their knowledge to medicines and vice-versa

Certifications:

  • CPD: 12 hours for your records
  • Certificate of completion

Key Topics Covered:

Day 1

Defining a drug/device and device/drug product

  • EU approach
  • US approach

Regulatory procedures for drug/device and device/drug products

  • EU procedures
  • US and Office of Combination Products

Understanding devices

  • Medical Device Regulation – EU
  • CE marking and Notified Body interactions
  • CDRH definitions – US – 510(k) and PMA
  • Labelling
  • Vigilance requirements

Device technical file/design file

  • What is required
  • Structure
  • Bench testing
  • Potential clinical requirements

Workshop: Technical file/design file

Understanding the biological and synthetic drug regulations

  • EU/US definition of medicinal product
  • Labelling
  • Pharmacovigilance
  • Quality requirements

Day 2

Registration procedures

  • EU approach
  • US approach

GMP and ISO standards

  • Practical application
  • Interpretation of the standards

The CTD

  • Where to put data
  • Data expectations
  • Applying QbD (quality by design)

Workshop: CTD requirements – tracking critical documents

Key considerations for the regulatory strategy

  • Deciding which regulatory route to take
  • Device and product registrations
  • Combination-only registrations
  • Desired labelling

Workshop: regulatory strategy

For more information about this training visit https://www.researchandmarkets.com/r/mquu9m

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course (Feb 11th – Feb 12th, 2026) – ResearchAndMarkets.com

Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course (Feb 11th – Feb 12th, 2026) – ResearchAndMarkets.com




Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course (Feb 11th – Feb 12th, 2026) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course (Feb 11th – Feb 12th, 2026)” training has been added to ResearchAndMarkets.com’s offering.


This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development or need to provide the regulators with specific usability data for their device to comply with the MDR.

The format for the day will be interactive with the presenter sharing his experiences as a specialist with extensive knowledge and understanding of the requirements of the MDR, IEC 62366 and FDA human factors Guidance. There will be questions posed for discussion and delegates will work through some of the key aspects of performing a successful human factors study.

Benefits of attending

  • Understand the requirements of IEC 62366 and FDA human factors Guidance
  • Know how to provide the regulators with specific usability data for your device
  • Understand human factors and the design process
  • Learn how to validate combination products
  • Consider human factors and risk
  • Discuss generic combination products – ANDAs and HF
  • Find out what HF data FDA requires for biosimilars

Certifications:

  • CPD: 12 hours for your records
  • Certificate of completion

Who Should Attend:

This event will be beneficial to those working in the following areas:

  • Engineering and device development
  • Packaging
  • Regulatory affairs
  • Quality systems
  • Quality assurance
  • Risk management
  • Marketing
  • Usability and human factors engineering

Key Topics Covered:

Introduction

  • Scope of the training
  • Expectations for the training

Background to human factors

  • Human factors, usability and ergonomics defined
  • Trends in drug delivery device technology
  • Use errors – scale, scope and implications
  • Defining the user interface
  • Usability research, clinical research and market research compared

Legal and regulatory requirements

  • US law and design control – implications for HF
  • MDR and usability requirements
  • Article 117 and implications for combination products
  • UK medical device regulations

IEC62366, FDA guidance and expectations

  • IEC62366 usability engineering process
  • FDA human factors guidance
  • ISO14971 applied to combination products
  • EMA guidance on combination products
  • Chinese human factors guidance 2022

Human factors methods and best practices

  • Human factors engineering
  • Perception, cognition and action model
  • Heuristic analysis

Design control, design and development

  • Design and development planning
  • Role of human factors in design control
  • UE methods and outputs
  • UE integration with combination product development

User needs & user interface specifications

  • Regulatory requirements for user needs
  • Defining formal user needs
  • User requirements and the design trace matrix
  • Building a user interface specification

Formative and validation testing methods

  • Formative testing methods
  • Human factors validation methods

Use-related risk

  • Regulatory requirements for use-related risk
  • ISO14971 applied to combination products
  • Risk analysis methods
  • Risk control
  • Residual risk analysis

HF and clinical trials

  • How HF and clinical trials differ
  • How to gather HF data during clinical trials
  • Changing the user interface during the trial program
  • HF requirements for INDs and IDEs

Technical data requirements

  • HF contents of a design history file
  • HF contents of a EU technical file

Predicate devices, platform devices and post-market surveillance

  • Platform devices – how to incorporate HF
  • Platform device due diligence
  • Post-market HF requirements – US and EU

Generic devices, biosimilars and ANDAs

  • How to do a database and literature search for known use problems
  • ANDA submissions and HF
  • ANDA versus 505(b)(2) HF requirements
  • FDA HF requirements for biosimilars

Practicalities – how to stay legal

  • GDPR, IRB, HIPAA and the Sunshine Act
  • When to apply for ethics/IRB approval
  • Common GDPR problems during HF testing

Wrap-up

  • Common pitfalls and top tips
  • Top tips

For more information about this training visit https://www.researchandmarkets.com/r/5s90py

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Successful Medical Writing from Protocol to CTD Training Course: Understand International Guidelines and Standards (Mar 23rd – Mar 24th, 2026) – ResearchAndMarkets.com

Successful Medical Writing from Protocol to CTD Training Course: Understand International Guidelines and Standards (Mar 23rd – Mar 24th, 2026) – ResearchAndMarkets.com




Successful Medical Writing from Protocol to CTD Training Course: Understand International Guidelines and Standards (Mar 23rd – Mar 24th, 2026) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Successful Medical Writing – from Protocol to CTD Training Course (Mar 23rd – Mar 24th, 2026)” training has been added to ResearchAndMarkets.com’s offering.


Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals.

This process largely relies on the quality of documentation submitted to the regulatory authorities, and a high standard of medical writing plays a vital role in ensuring a positive outcome. This intensive three-day medical writing course will help you to improve your skills and achieve this standard.

Who Should Attend:

The course will be of interest to all those in the pharmaceutical industry who prepare research reports and documentation intended for regulatory authorities. Although the focus of the seminar is on clinical research, many of the principles will also apply to other types of reports, including pre-clinical, CMC and veterinary documentation. The practical training will benefit not only those new to medical writing, but also those wishing to perfect their existing writing skills, including full-time medical writers and those who only occasionally write research documentation or regulatory submissions.

Benefits of attending

  • Gain in-depth knowledge on general writing and data presentation skills, specifically in the kind of documents most frequently encountered in clinical research
  • Understand the international guidelines and standards
  • Explore both the theoretical and practical aspects of writing for regulatory authorities through illustrative examples

Certifications

  • CPD: 12 hours for your records
  • Certificate of completion

Key Topics Covered:

Day 1 – Fundamentals of Regulatory Medical Writing

Introduction to Regulatory Medical Writing

  • Overview of medical writing in the pharmaceutical industry
  • Types of documents
  • Project management
  • Working cross-functionally
  • Document reviews
  • Quality checks

Regulatory environment and guidelines

  • Regulatory agencies and key regulatory guidelines
  • Drug development lifecycle and regulatory milestones

Regulatory documents

  • What are they and why are they needed?
  • Developing the protocol and ICFs
  • Developing the CSR
  • Developing the Investigator’s Brochure
  • Developing the DSUR

Day 2 – Scientific Advice and Marketing Applications

Briefing documents

  • What are they?
  • Why are they needed?
  • How are they developed?

Importance of real-world evidence and patient-centred outcomes

The Common Technical Document

  • Introduction to clinical submission dossiers
  • Writing the clinical overview & the clinical summary

Speakers:

Cheryl Roberts-Vitalis

BioMarin Pharmaceutical Inc.

Cheryl is currently the Global Head of Medical Writing at BioMarin Pharmaceutical Inc., and specialises in medical writing for serious and life-threatening rare diseases. She joined the pharmaceutical industry in 2001 in drug development, and continued in positions in medical editing and medical writing in both the pharmaceutical and consultancy industry. She holds a degree in Medical Biology and a Masters in Neuroscience. Cheryl has been an approved workshop leader for the European Medical Writers Association since 2015 and gives training on subgroup analyses and orphan medicinal products.

For more information about this training visit https://www.researchandmarkets.com/r/2lk8xk

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900