Certificate of Pharmaceutical Product (CPP): Implementation and additional requirements in Asian and African countries
The Certificate of Pharmaceutical Product (CPP) is a document based on a format recommended by WHO which establishes the status of a pharmaceutical product and of the applicant for this certificate in the exporting country. Its implementation enhances the availability of new drugs in developing countries. However, despite the standard format, each country has its own additional requirements. The objective of this poster is to display the additional requirements among 23 Asian and 11 African countries.
The regulatory requirements of certain Asian and African countries as implemented between 2019 and 2021 were collected. The countries in scope from Asia were: Cambodia, Bangladesh, Kazakhstan, Indonesia, Malaysia, Philippines, Iraq, Russia, Macao, Lebanon, Sri Lanka, Belarus, Vietnam, Oman, United Arab Emirates, Qatar, Bahrain, Kuwait, Taiwan, Nepal, India, Myanmar, Jordan. The countries in scope from Africa were: Libya, Egypt, Uganda, Nigeria, Ghana, Mauritius, Kenya, Rwanda, Zambia, Ethiopia, Tanzania.
After examining the additional requirements of each country, the results for Asia were as follows; 1 country (Iraq) requires the statement of the shelf-life in addition to the CPP. 19 countries (Cambodia, Bangladesh, Indonesia, Malaysia, Iraq, Macao, Lebanon, Sri Lanka, Belarus, Vietnam, Oman, United Arab Emirates, Qatar, Kuwait, Taiwan, Nepal, India, Myanmar, Jordan) require the statement of the marketing status as well as the marketing date of the respective product in the exporting country. 13 countries (Jordan, India, Nepal, Kuwait, Bahrain, Qatar, United Arab Emirates, Oman, Sri Lanka, Iraq, Philippines, Indonesia, Bangladesh) require the Summary of Product Characteristics and/or the Patient Information Leaflet in the exporting country (preferably as an English translation). 3 countries (Myanmar, India, Macao) require notarized CPP. 9 countries require embassy legalization of the CPP in the exporting country (Jordan, Taiwan, Kuwait, Qatar, United Arab Emirates, Vietnam, Lebanon, Iraq, Bangladesh) while 5 countries (Bahrain, Oman, Belarus, Russia, Kazakhstan) require legalization of the CPP via Apostile.
As far as Africa is concerned the results were as follows; 10 countries (Libya, Uganda, Nigeria, Ghana, Mauritius, Kenya, Rwanda, Zambia, Ethiopia, Tanzania) require the statement of the shelf-life in addition to the CPP. 11 countries (Libya, Egypt, Uganda, Nigeria, Ghana, Mauritius, Kenya, Rwanda, Zambia, Ethiopia, Tanzania) require the statement of the marketing status and the marketing date of the product as well as the Summary of Product Characteristics and/or the Patient Information Leaflet in the exporting country (preferably as an English translation). 6 countries (Libya, Egypt, Nigeria, Zambia, Ethiopia, Tanzania) require embassy legalization of the CPP in the exporting country. 5 countries (Uganda, Ghana, Mauritius, Ken

Certificate of Pharmaceutical Product (CPP): Implementation and Additional Requirements in Asian and African Countries

We conducted a survey of 146 individuals in the U.S., Europe and China who worked at small, mid-sized and large biopharmaceutical companies about their use of, and attitudes towards, sensors in clinical trials. Additionally, deep-dive interviews with 10 U.S.-based respondents were conducted.

Results from a Survey of Biopharmaceuticals on Attitudes Towards the Use of Wearables and Sensors in Clinical Research

Semi-structured interviews with European clinical regulators were conducted between May and October 2021. Representatives from all European competent authorities were invited. The topic guide included scientific and operational aspects of DCTs. Data were analyzed according to thematic analysis.

Challenges and Opportunities for Conducting Decentralized Clinical Trials: The European Regulators’ Perspective

Stakeholders including patients, distributors, and healthcare providers such as nurses, pharmacists, doctors, dealing with protein drug products will undergo qualitative research interviews using an interview schema created considering initial stakeholders’ feedback.

Qualitative Research on Real Handling of Protein Drug Products in RealHOPE

Between May and July 2021, a survey was sent out to current or former healthcare payers from CEE and ME countries. The survey questioned the current use of and future preferences for reimbursement and payment models using Likert scales, and the perceived barriers through open questions.

Reimbursement and Payment Models in Central Eastern European and Middle Eastern Countries: Current Use and Future Outlook

Objectives: 
To identify the products approved with the medication error (ME) defined as a safety concern in the risk management plan (RMP) and to evaluate the routine and additional risk minimisation measures (rRMMs and aRMMs) for those products, implemented in the European Union to minimise the risk of ME.
Methods: 
A descriptive analysis of the EPARs, RMP summaries and Annex IID was carried out for the products authorised by a centralised procedure from Jan-2015 to Dec-2021 to identify the medicines with ME as a safety concern along with the type of risk minimisation measures approved for them.
Results: 
During Jan-2015 to Dec-2021, 548 CAPs were approved, of which 400 were included in this study. At the time of the study, generic products were excluded, as they follow the originator product to support their documentation. Out of 400 products, 22% (n=86) were found to have ME as a safety concern. In the EU-RMP, of these 86 products, 13% (n=11) were categorised as having an important identified risk and 87% (n=75) as having an important potential risk. The majority of ME-related safety concerns were identified for intravenous (IV) route (40%), followed by oral (28%), subcutaneous (SC) (12%), sublingual (3%), intramuscular (3%) and nasal (5%) routes. ME as a risk and steps to minimise it were described in the rRMMs for all (100%) the products and 38% of the products also had aRMMs for this safety concern.
From rRMMs perspectives, other than the SmPC and PIL, pack size restrictions were identified for 13% of the medicines, which have a risk of accidental/fatal overdose due to ME. Additional warnings on the labelling and packaging were identified in 27% of the medicines where colour coding for different presentations and pictorial representation of method of administration were observed. The legal status of the medicines was found as ‘Restricted medical prescription’ for 85% of the medicines and ‘Prescription only medicines’ for 15% of the medicines.
In aRMMs, 35% of the products were approved with the educational materials (EMs), 4% with the DHPCs and 1% with controlled access programme in addition. In EMs, 79% of the products were approved with EMs for HCPs, 58% with EMs for patients and 46% received approval with EMs for both patients and HCPs. The DHPCs were providing information regarding preparation and administration of IV medicine, whereas EMs for HCPs were providing information regarding the route of administration (IV, intramuscular [IM] and SC) and instructions to be given to the patients. EMs for patients were focusing on the method of use for sublingual, nasal and ocular formulations.
Conclusion: 
Medication error-related safety concerns were listed for almost a quarter of the CAPs approved during the study period. The majority ofME-related safety concerns was identified for intravenous route, which suggests a lack of training at the HCPs' end, either during preparation of these medicines or during administration and monitoring.
It is

Evaluation of Risk Minimisation Measures Implemented in the European Union for Medication Errors

Members of research ethics committees and competent authorities from multiple European countries discussed and reviewed a fictitious phase IV randomized fully decentralized clinical trial protocol in focus group sessions.

Ethics review of Decentralized Clinical Trials (DCTs): Results of a Mock Ethics Review

Publicly available protocols from Phase 2, 3, and 4 interventional clinical trials investigating a medicinal product with a trial start date in 2019/20 were downloaded from ClinicalTrials.gov. Information on predefined decentralized elements and on-site equivalents was manually extracted.

Decentralized Trial Elements Reported in Publicly Available Clinical Trial Protocols

Payers across Europe have experimented with the implementation of benefit-sharing programs to support the rational prescribing of biologics. This study addresses knowledge gaps concerning benefit-sharing strategies and provides recommendations for their optimal design and implementation. 
This study is based on a literature review and on semi-structured interviews with payers/insurers, policy-makers, healthcare professionals and industry representatives in England, France, Germany, Ireland, Italy, the Netherlands, Poland, Portugal, Romania and Scotland.
Our analysis revealed very variable design characteristics for benefit-sharing programs, depending on the organisation of the healthcare system, the specific time frame, the care setting and the policy environment. We also noted a generalised lack of transparency regarding the distribution of savings and how they are reinvested. This has raised questions on how to properly engage all stakeholders and on how to optimally implement benefit-sharing in the future.
To realise the full potential of benefit-sharing programs we identify the importance of 1) setting-up and timely monitoring success indicators for these programs; 2) including quality of care parameters as success indicators; 3) establishing clear pathways for the transparent distribution of savings; 4) transparently communicating with patients about the outcomes of benefit-sharing programs.

Benefit-Sharing Programs for Biologics: A European Comparative Analysis of Implementation Challenges

There are many types of interventional research and laws that regulate them in Japan. This paper discusses an overview of bodily health damage compensation and clinical research insurance for interventional research.
”Indemnity" is an act by which a person who has intentionally or negligently infringed on the rights or benefits of another person compensates for the damage caused by the infringement, and liability for compensation is defined by the Civil Code (Tort Law).
The Tort Law stipulates that the person responsible for compensation shall make up for damages caused by carelessness or negligence, which could have been avoided if sufficient care had been taken, such as contamination of test drugs with foreign substances, defects in research plans, inadequate informed consent, and medical malpractice. Since this is a responsibility under the Civil Code, it is not necessary to include it in the research protocol, but researchers and clinical research institutions should purchase physician liability insurance in advance to prepare for medical errors in general practice and clinical research.
On the other hand, "compensation" refers to making up for the disadvantage of the subject caused based on the lawful act. Specifically, it is a case where the test drug was manufactured properly, the researcher conducted the clinical research properly based on the research protocol, and there was no medical malpractice, but health damage such as side effects unfortunately occurred, and no one is legally responsible under the Civil Code because no one committed intentional or negligent acts. In this case, compensation is the act of compensating for the subject's damage by setting up a social relief system based on welfare principles. Examples of compensation in the medical field include the Health Damage Relief System for Vaccinations, the Adverse Drug Reaction Relief System, the Biological Product Infection Relief System, the Blood Donor Health Damage Relief System, and the Obstetric Medical Compensation System.
At present, several domestic and foreign non-life insurance companies are selling clinical research insurance products. This insurance consists of liability insurance plus a special contract for compensation. The liability insurance portion compensates for health damage caused by negligence in clinical research procedures, excluding medical treatment, such as inadequate research plans, misregistration of unqualified subjects, and informed consent with inappropriate explanatory documents. In other words, it does not include physician liability for medical treatment, nor does it cover product liability for post-marketing drugs, medical devices, and regenerative medicine products. The special contract on compensation is based on the "Guidelines for Compensation of Health Damage to Human Subjects" of the Pharmaceutical Companies Legal Study Group and the Pharmaceutical Adverse Reaction Damage Relief System, and is designed to pay compensation for death an

Compensation for Bodily Health Damage Related to Clinical Research, and Clinical Research Insurance in Japan

Semi-structured interviews were carried out in-person or over zoom with a purposive sample of stakeholders between 31/01/2020 and 26/06/2020. The interview data were coded using a thematic approach, identifying similarities, differences, and clustering to generate descriptive and theoretical themes.

Learning from Decentralized Clinical Trial (DCT) Experiences: A Qualitative Analysis of Interviews with Stakeholders

Objectives: Following the rise of precision medicine, real-world evidence (RWE) has been playing an increasingly important role in the development of anticancer therapies. Regulators, payers and health technology assessment agencies are more and more relying on RWE to inform and support their decision-making. However, it is unclear how cancer clinicians perceive this trend, and the value they attribute to such evidence has not been properly characterized before. The objective of this study is to gain insight into their views on the use of RWE in the field of oncology.
Methods: We designed an online survey that was disseminated to clinicians who are part of the EORTC network, which comprises over 2,500 investigators.
Results: 557 clinicians across 30 countries provided responses to the survey, representing 13 different cancer domains. The vast majority (77.0%) of the respondents believed that randomized controlled trials (RCTs) should still be considered the gold standard for generating clinical evidence in oncology, and a plurality (49.2%) thought that RWE cannot fully address the knowledge gaps that remain once a new antineoplastic treatment has entered the market. Furthermore, most (50.7%) investigators relied more strongly on RCT-derived evidence than on RWE for their decision-making. Nevertheless, despite not agreeing on its most appropriate definition, 75.0% of the survey participants had positive opinions about RWE, and many (77.0%) clinicians were supportive of the idea that such evidence would play a greater role in the development of antitumor interventions in the future. Nearly all (94.0%) respondents were also at least open to the possibility of sharing anonymized or pseudonymized data of their patients with external parties for research purposes.
Conclusions: While cancer clinicians continue to place great value on RCTs as sources of evidence, they view RWE positively, and they would be willing to contribute to its generation.

Perceptions of Clinicians on the use of Real-World Evidence in Oncology: An EORTC Survey

Between 11/02/20 and 31/03/20, we searched academic databases, ClinicalTrials.gov, and relevant websites for publications reporting or discussing DCT methods. We conducted a quantitative analysis of DCTs and a thematic qualitative analysis of all publications.

A Systematic Review of Methods used to Conduct Decentralised Clinical Trials

Objective: With increasing treatment options for patients suffering from inflammatory bowel disease (IBD), we aimed to qualitatively evaluate the disease and treatment characteristics IBD patients find most important. 
Method: This qualitative study consisted out of i) a scoping literature review, ii) two focus group discussions with Belgian IBD patients (n=11) using the nominal group technique, and iii) a qualitative thematic analysis using the framework method.
Results: IBD patients with varying disease and treatment characteristics found it key that treatments would reduce the frequency and severity of their gastrointestinal symptoms (e.g., diarrhea, urgency, incontinence, nocturnal defecation, bowel movements, constipation, and abdominal cramps) and therefore decrease the symptoms’ negative influence on both psychological and social aspects of quality of life. Vision problems and reduced energy were highlighted as major issues, reducing patients’ ability to live their normal lives. Participants also discussed the negative impact of following symptoms and adverse events on their body-image: severe skin conditions, fluctuations in body weight, hair loss, developing facial hair, and developing a moon face. IBD patients attached great importance to the uncertainties and fears they experienced regarding the effectiveness and onset of action of their medication, the long-term effects, and the possible need for surgery or an ostomy. Participants also extensively discussed the mental aspect of having IBD and the guidance, support, and communication with healthcare workers regarding patients’ emotional well-being.
Conclusion: This study acquired an in-depth understanding of the treatment and disease-related characteristics that are most important to IBD patients. Results show that IBD drug development and individual treatment decision-making does not only need to focus on controlling IBD patients’ gastrointestinal symptoms, but also on other symptoms and adverse events that significantly impact IBD patients’ quality of life. These findings will be used in a subsequent quantitative study. This study further underscores the need for a transparent communication between healthcare providers and IBD patients. In addition, more consideration should be given to the psychological problems and emotional well-being of IBD patients. Finally, the obtained results may give insights to drug developers and other stakeholders (regulators, health technology assessment bodies, payers, and clinicians) about the unmet medical needs IBD patients have regarding available treatments, and therefore can aid patient-centric decision-making across the drug life cycle.

Patient Preferences for Inflammatory Bowel Disease: A Qualitative Study in Belgium

In 2011, the FDA launched its Case for Quality. As part of that initiative, the FDA and members of the Medical Device Innovation Consortium (MDIC) met repeatedly to discuss and develop a strategic plan and define specific initiatives to move companies from a culture of compliance to a culture of quality. Compliance focuses on meeting regulatory requirements, whereas a culture of quality embodies the principle of continuous improvement and focuses on customer (providers and patients) needs. One of these initiatives has led to a Leadership Engagement Playbook that describes best practices.
Quality is integral to the entire organization. A survey among MDIC members taken during the initiative highlighted the importance of leadership, role definition, behaviors, and communications, and revealed where companies were falling short. The team then collected best practices and crafted a playbook that provides guidance in 10 key areas: Facilitate a Culture of Quality, Develop a Quality Strategy, Make Quality a Priority, Measure the Value of Quality, Be Proactive - Not Reactive, Clearly Define Quality at the Individual Level, Encourage Quality Behaviors, Use Quality Benchmarking, Use Quality Metrics, and Recognize and Reward Quality. The panel members will present the key principles embodied within the playbook as well as their personal experiences implementing quality programs in their organizations.

Leadership Engagement: Fostering a Culture of Quality

Risk Management and Minimization in Early Clinical Development:
“Designing with the End in Mind” in a Setting with Little Data
Ideally, risk management begins early in clinical development, to ensure that the safety profile of a drug is explored at a point where it is easier to make changes to adapt to biological reality. Given the limited number of subjects studied, using all available data to identify potential signals is key. However, the tension between understanding a drug’s safety profile and providing enough evidence of efficacy to warrant further study can inhibit detailed analysis. In contrast to the post-marketing setting, in early trials detailed and accurate safety data can be obtained, but the small number of subjects limits statistical approaches. Furthermore, relevant data may reside in different functions, requiring effective cross-functional collaboration. Patient safety is directly impacted by resulting decisions.
The new FDA draft guidance, “Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies Draft Guidance for Industry” released in June 2021 adds both complexities and solutions to this enduring dilemma. It suggests comparing the incidence of ‘anticipated events’ to that of an untreated population to trigger an Aggregate Analysis to determine the presence of a signal that would require expedited reporting. However, our industry survey showed none of the small or startup companies having begun planning for implementation. We present a use case that combines patient exposure and the incidence of anticipated events to set a trigger for Aggregate Analysis.
Results of the proposed approach showed that statistical modeling of exposure versus ‘anticipated event’ frequency provides the number of SAEs for a given medical condition that would indicate a >80% probability of increased risk, allowing for focused analysis of clinical data sets even with the limited data sets in early development. The resulting Aggregate Analysis combines medical and statistical approaches to focus on potential signals. Prospectively determining incidence rates for ‘anticipated events’ remains a significant challenge. Use of all available data for Aggregate Analysis is key to understanding the emerging safety profile.
By using the concept of ‘anticipated events’ with appropriate statistical modeling, as well as aggregate analysis; the challenges of early clinical development can be addressed to assure patient safety and effective drug development with smaller data sets. This approach focuses on early signal detection, employs appropriate statistical modeling within a traditional pharmacovigilance framework, and addresses the challenges put to industry by the June 2021 FDA draft guidance.

Risk Management and Minimisation in Early Clinical Development: “Designing with the End in Mind” in a Setting with Little Data

Title: Patient preference studies in drug development and evaluation: views from European drug regulators
Objectives: This study aimed to: i) understand drug regulators' experience and understanding of patient preference studies, ii) identify regulators' priorities affecting the use of preference studies, and iii) explore steps moving forward regarding patient preference studies in drug development and regulation
Methods: An online survey was widely spread through the European regulatory network, from August 3rd 2020 to September 22th 2020. The survey was developed based upon a scoping literature review and a focus group discussion with European drug regulators using Nominal Group Technique (n=6). 
Results: 72 European drug regulators completed the survey. Participants were heterogeneous regarding their period in function as drug regulator (M: 8 years), regulatory and disease expertise, and affiliated national competent authority. While only 55% had heard about patient preference studies prior to participation, 90% wanted to learn more about them. Regulators argued that in order to move toward using patient preference studies, there is a need to: i) improve their understanding on preference methodologies and how they would benefit their assessment, ii) provide incentives towards regulators and other stakeholders to systematically incorporate preferences in drug development and evaluation, iii) augment widespread availability of high-quality and unbiased preference studies, iv) develop quality criteria to standardize preference study conduct and evaluation, and v) increase interactions between stakeholders on robust preference study designs.
Conclusion: Best practice patient preference studies, European regulatory guidelines, educational tools and multi-stakeholder discussions involving regulatory authorities, health technology assessment bodies, academia, and patient organizations could all serve in increasing regulatory value and application of patient preference studies and are great opportunities to establish more knowledge among European drug regulators and other stakeholders.

Patient Preference Studies in Drug Development and Evaluation: Views from European Drug Regulators

In January 2020, we disseminated a questionnaire to 33 European HTA organisations that are members of EUnetHTA. The survey was validated and tested for reliability by an expert panel, and pilot-tested before dissemination via LimeSurvey. Results were analysed using descriptive statistics.

Real World Data in Health Technology Assessment of Complex Health Technologies

Objectives: This study aimed to portray exemplified insights into how stakeholders across the medicinal product life cycle (such as drug developers, regulators, Health Technology Assessment (HTA) bodies, payers, and clinicians) can integrate preference study evidence into their decisions.
Methods: First, a literature review of regulatory guidelines and empirical studies eliciting stakeholder views on preference studies was performed in June 2021. Second, the results of a preference study in Multiple Myeloma (MM) were evaluated against the preference study roles identified in literature.
Results: Evaluating the MM study results against the preference study roles identified in literature revealed several potential applications for the MM study along the medicinal product life cycle. First, the MM study can be used by pharmaceutical companies to allocate resources towards developing drugs that not only improve life expectancy but as well target quality-of-life related symptoms and side-effects, such as mobility problems, pain, neurotoxicity's, and thinking problems. Second, results from the MM study may support regulators and HTA bodies in requiring drug developers to augment evidence about how MM treatments perform against these patient-relevant quality-of-life related side-effects and symptoms. Third, the MM study findings can be used by regulators and HTA bodies during benefit-risk assessment and relative effectiveness assessments respectively to increase their understanding of whether the MM treatment being evaluated address the unmet needs, symptoms, side-effects and uncertainties most important to patients. Finally, the MM study may inform healthcare providers about which (long-term) MM treatment-related uncertainties, symptoms, and side-effects should be systematically and clearly communicated to patients during individual treatment decision-making in clinical practice.
Conclusion: This study portrays multiple concrete opportunities for patient-centered and robustly conducted preference studies in informing decision-making across the medicinal product life cycle. Future efforts should seek to leverage internationally accepted guidelines, joint horizon scanning activities, early scientific advice, and parallel consultations by regulators and HTA bodies to formalize the designated role, requirement and design of patient preference studies in drug development and evaluation.

Integrating Patient Preference Studies in Decision-Making Across the Medicinal Product Life Cycle: A Case Study in Oncology

Abstract Title: Effectiveness of a Global Web-Based Pharmacovigilance Educational Platform as a Learning, Communication, and Networking Tool
Tuba Nihan Doruk, Tina DelMonte, Shivraj Sharma, Mirza Rahman
Objective:
To assess the effectiveness of a comprehensive web-based pharmacovigilance (PV) educational platform (Global PV Academy) as a learning, communication, and networking tool since it was revamped in 2018, with a focus on company products, therapeutic areas, and organisational/regulatory updates.

Effectiveness of a Global Web-Based Pharmacovigilance Educational Platform as a Learning, Communication, and Networking Tool

Objective
To illustrate the positive impact on enrollment, retention, and patient burden of deploying a decentralized clinical trial (DCT) and a well-trained team of mobile nurses to a phase 2 exploratory study of hydroxychloroquine dosing and adherence among children with lupus.

Combining DCT Technology, Effective Mobile Nursing and Connected Devices To Deliver Pediatric Clinical Trials At Home

This study is a 2-center, exploratory interventional study in the US. Recruitment started in 2017. A total of 189 healthy babies were included and 84 completed the study until today. Five brain MRI visits are planned on 3, 6, 12, 18, and 24 months of age. Cognitive and behavioral assessments are performed.

MRI Study In Healthy Babies: Operational Challenges and Impact of Covid Pandemic

Background: Beyond evaluation and  approval, European and national regulators have a key role in providing  reliable information on biosimilars and the science underpinning their  development, approval, and use.
Objectives: This study aims to (i)  review biosimilar information and guidance provided by EMA and national  medicines agencies and (ii) explore stakeholder perspectives on the role  of regulators in enabling acceptance and use of biosimilars.
Methods: This study consists of (i) a comparative review of regulatory information and position statements across medicine agencies (n = 32) and (ii) qualitative interviews with stakeholders in Europe (n = 14).
Results: The comparative analysis  showed that regulatory information and guidance about biosimilars  offered by national medicines agencies in Europe varies, and is limited  or absent in multiple instances. Approximately 40% (13/31) of the  national medicines agencies' websites did not offer any information  regarding biosimilars, and for about half (15/31) no educational  materials were provided. Only less than half of national medicines  agencies provided guidance on biosimilar interchangeability and  switching (8/31 and 12/31, respectively). Among the national medicines  agencies that did offer guidance, the extent (e.g., elaborate position  vs. brief statement) and content (e.g., full endorsement vs. more  cautious) of the guidance differed substantially. Countries that have a  strong involvement in EU level biosimilar regulatory activities  generally had more elaborate information nationally. Interviewees  underwrote the need for (national) regulators to intensify biosimilar  stakeholder guidance, especially in terms of providing clear positions  regarding biosimilar interchangeability and switching, which in turn can  be disseminated by the relevant professional societies more locally.
Conclusion: This study revealed that,  despite strong EU-level regulatory biosimilar guidance, guidance about  biosimilars, and their use differs considerably across Member States.  This heterogeneity, together with the absence of a clear EU-wide  position on interchangeability, may instill uncertainty among  stakeholders about the appropriate use of biosimilars in practice.  Regulators should strive for a clear and common EU scientific position  on biosimilar interchangeability to bridge this gap and unambiguously  inform policy makers, healthcare professionals, and patients.  Furthermore, there is a clear opportunity to expand information at the  national level, and leverage EU-developed information materials more  actively in this regard.

Regulatory Information and Guidance on Biosimilars and their Use across Europe: A Call for Strengthened One Voice Messaging

A comprehensive search strategy was employed to identify studies published until October 2021 and indexed in five databases: Web of Science, Embase, Medline, Cinahl, and ProQuest. The review was carried out in different phases: study identification, screening, data extraction, and identification of

Application of Machine Learning Methods in Predicting Adverse Drug Reaction in Geriatric Population

DIA Europe 2022

A global, member-driven non-profit organization mobilizing life sciences and healthcare. DIA fosters innovation to improve health and well-being worldwide. Professionals from 80 countries continue to engage with DIA through our unparalleled membership network, educational offerings, and professional development opportunities.