As a direct result of the outbreak of the Coronavirus disease (COVID-19) and due to circumstances beyond our control, LS Academy has decided to postpone the International Pharmacovigilance Day 2020 in Madrid to 14 and 15 September 2020.
A Global Pharmacovigilance Network: Opportunities and Challenges
LS Academy is delighted to welcome you to the 2nd International Pharmacovigilance Day conference to be held on 13th & 14th May 2020 in Madrid, Spain. The pharmacovigilance world is undergoing a phase of rapid change with new technologies, dynamic regulations and increasing complexity in data sources.
This one-and-a-half-day event will showcase renowned international speakers addressing hot topics in pharmacovigilance and highlighting the opportunities and challenges in managing them. Among the main topics of the day:
- Dynamic international PV legislation: what’s hot right now
- Regulatory Authority viewpoint: the new inspection mood
- New Safety regulations affecting device-drug and drug-device combination products
- New PRAC strategy for impact assessment of pharmacovigilance
- Digital Health: New initiatives, new information sources, big data and social media
- Handling safety information received via digital health apps
- WEB-RADR & new technologies
- Electronic Product Information & creating a product e-label
- Developing effective global PV systems
- Pharmacovigilance in first-in-human trials & monitoring
- ePatient involvement
And much more!
A pool of exceptional international experts addresses and compares on the hot topics that arise on a daily basis and on an international scale.
Participants will have the opportunity to take part in up-to-date discussions and to share their own experiences within greatly qualified international expertise.
The International PV Day attractive traits include:
- A Scientific Committee guaranteeing updated and strictly scientific topics, quality discussions and absence of any commercial presentations.
- Different international perspectives presented over the event: regulatory authorities, industry, CROs
- Open discussions and group working sessions.
- Notable networking opportunities.
- An easy to access venue and friendly environment.
The event is fully designed for professionals involved in medicines or device safety, pharmacovigilance, digital healthcare, clinical research, development and management of pharmaceutical and combination products.
LS Academy, leader in the field of scientific continuing education, welcomes you to an outstanding International Pharmacovigilance event for constant professional development and up-to-date discussions in this extremely relevant scientific area.
Irene Doris Stenver, Independent Pharmacovigilance Adviser, Founder of Unique Advice
Jabeen Ahmad, Independent Pharmacovigilance Consultant
Pilar Carrero, QPPV Office Vice President at Novo Nordisk A/S
Rebecca Webb, Director of Pharmacovigilance Quality Assurance at AbbVie
Who should attend?
This conference is designed to benefit functional/technical professionals working in the pharmaceutical and health care area dealing with the Pharmacovigilance system, such as: Safety and Pharmacovigilance dept, Clinical operation dept, Statistic dept, Medical Affairs dept, Medical Information dept, Regulatory Affairs dept, Quality & Compliance dept, Legal dept, Software Developing dept, Medical Devices Manifacturing Companies, University Faculties scientists who are related to clinical and medical research (Senior, Associate and Assistant Professors, Research Scholars, Phd students). Also, Directors/Seniors Directors/Executive Directors and Vice Presidents /Senior Vice Presidents/Executive Vice Presidents and Heads/Leaders/Partners of: CROs and CMOs, Clinical Research Sites, Pharma, Biotech and Medical Devices Industries.
For sponsorship opportunities, please contact firstname.lastname@example.org
14 Settembre 2020
The Medical Device Directive is phased out by May 2020. That means that at the day of the convention in Madrid, the Medical Device Regulation (MDR, Regulation (EU) 2017/745) is active in full force. All companies that have a medical device on the EU market have to comply with the regulation. That also applies to companies that have a combination product on the market or in development phase.
This will affect the required documentation necessary for product registration (technical file, Annex II, MDR) but is also affecting the company procedures. Article 10, paragraph 9 dictates which processes require a documented procedure. Note (22) of the MDR indicates that following the ISO13485:2016 is highly desirable. When combining these requirements with article 117 of the MDR regarding combination products, it becomes clear that “pharma” companies with a combination product, become subject to the above.
Since focus on clinical evidence is increased under the MDR, this will not only affect the clinical evidence collected before product registration but it will also affect the vigilance processes. The pharmaco vigilance processes that are quite often followed for combination products, should also comply with the requirements for medical device vigilance.
In this presentation 2 main themes will be covered:
- An overview of the mandate and activities of the Pharmacovigilance Risk Assessment Committee (PRAC)
- The PRAC strategy to measure impact of pharmacovigilance
The EU pharmacovigilance system has been strengthened significantly following the implementation of the comprehensive renewed legislation in 2012. There are many indications, that the EU pharmacovigilance network is robust and effective. However, it is desirable to widen the knowledge base with regard to the effectiveness of regulatory interventions. This is the main objective with the recently launched PRAC strategy on impact assessment. The key components of the strategy, examples of impact studies and guidance for impact research will be presented.
Randomized controlled clinical trials -RCTs -have long been the backbone of drug development. They are however often conducted in very structured and homogenous populations – and long term effectiveness is largely understudied. Now Real World Data (RWD) together with novel analytical methods provides new opportunities for generating another type of evidence – Real world evidence (RWE).
The challenges surrounding meaningful interrogation of such data for regulatory decision making will be discussed.
Also opportunities from Artificial Intelligence (AI)-based analyses will be discussed from a regulator’s perspective in the context of the need for valid, representative, reliable and methodology. Good Machine Learning practices will be discussed.
Whenever a Marketing Authorisation Holder (MAH) is in control of a digital media, such as an app, the MAH has an obligation to regularly screen data entered in this app. The obligation to screen is enforced to ensure that safety information related to the use of the MAH’s product is captured, considered and reported if constituting a valid case. The frequency of screening should allow for cases to be reported to the Health Authorities within the regulatory submission timelines.
Digital health apps have become increasingly accessible for users and the many data entered in the apps may potentially increase our knowledge on actual use and experience with medicinal products and devices, ultimately resulting in improvement of products and better medicines to patients.
The increasing amount of safety information received via such apps, however, have left room for several challenges. The incoming data must be treated in accordance with GVP requirements, in compliance with GDPR, and at the same time ensuring that patient safety is in focus.
In addition to the safety compliance considerations, attention to customer service and technical support are also needed.
This presentation provides one approach and considerations related to the handling of safety information received via digital health apps.
15 Settembre 2020
Pharmacovigilance in Latin America and the Caribbean has rapidly developed in recent years, with divergence in country-specific PV requirements and inconsistent implementation of global harmonization (ICH). Differences in organization and levels of development necessarily imply that a single approach is not suitable for all countries. Harmonization should be achieved through a scientific consensus process with regulatory and industry experts working side by side. Very often, National Medicines Regulatory Authorities introduce their own standards and regulatory pathways that do not meet international standards and best practice, or try to modify standards from the US Food and Drug Administration and EMA.
Currently there is an urgent need for harmonization, as e.g. for ICSRs, the submission timelines for expedited reports can vary from 24 hours to 15 days and from local format and language to English CIOMS I. Among others, this divergence hinders efficiency, exchange of information among regulators and proactive safety science.
Globalization of the pharmaceutical industry has prompted efforts to toward harmonization of PV practices worldwide to reduce risk, gain efficiencies and achieve a PV system that ensures patient safety is protected.
Last year, EFPIA IPVG LATAM group conducted a survey in order to assess the impact of lack of harmonized Pharmacovigilance (PV) requirements in LATAM with the main aim to understanding key requirements with a significant impact to Industry and to identify strategies for developing partnership with NCA within LATAM region.
Today patients are largely unaware about clinical trials, translational research, personalized medicine and their potential supportive role in their own treatments. And yet patients are in the best position to report an adverse reaction, as they have a unique personal knowledge and experience of the effects of the medication they take, on their body as well as their daily lives. Patients usually report adverse reactions to their doctor. But few doctors actively participate to report these events to the Pharmacovigilance System.
During this session the patient viewpoint will be presented: a real life experience of a patient on acute treatment like oncology and an example of treatment for a chronic disease in a clinical trial setting.
This session will include an interactive discussion focused on the important and actual questions:
How can we incorporate the patients’ voice & perspectives into the pharmacovigilance system in order to bring safety to patient?
The ultimate goal of this session is to portray the daily life of patients, to demonstrate the windows of opportunity within our patient safety and pharmacovigilance processes to integrate patient perspectives. The presenters will also share their experience on the capabilities that patient experts need to successfully contribute to medicines research and development and to become active partners with academia, industry, regulatory agencies and ethic committees.
Current trends for – often misaligned - local pharmacovigilance regulations, multiple CRO/partner engagements, and the raise of digital health make managing pharmacovigilance across the globe an increasingly difficult task. The role of drug safety professionals is changing with demands to balance operational excellence, compliance and oversight across the global pharmacovigilance system.
This session will provide some examples on current challenges, and how current regulatory, societal and technology environments are shaping the future of PV professionals.
The WEB-RADR project concluded at the end of March with a number of exciting tools developed with potential for re-use in different settings. In this session the MHRA will describe what technology is currently available, their vision for the future of digital pharmacovigilance and some of the experiences from those that have been using the tools so far. The session will also explore the opportunities for pharmaceutical industry to benefit from the tools, and some of the key decisions and lessons that have been learnt during the project.
The role of patients is more important than ever. An empowered patient likes to engage more with its health and has rising needs for trusted information. They are researching for their symptoms and are taking greater control of the treatment of their disease. Due to modern technologies patients are no longer satisfied with static pdfs of patient leaflets on the web - they want information about their medicines that takes advantage of all the options available with modern technology they have at home and sharing their own experiences. How are we going to handle this challenge? How can we make important information for patients and Pharmacovigilance more easily accessible, improve its readability and allow for an interactive communication? Is there an opportunity for new ways of measuring risk minimization activities?
The session will talk about the importance of changing the existing static information into something flexible, and addressing rising use cases while connecting the dots between the different stakeholders. It will touch upon the current discussion on European level, highlight some ongoing initiatives and explore potential benefits based on use cases.
Many National Regulatory Agencies (NRAs) are focusing on building PV systems in countries where there has not previously been established mature PV frameworks.
In this context, national legislative bodies and NRAs have issued a significant amount of legislation and guidance in recent years to provide for the legal foundation and the practical implementation of pharmacovigilance. These new national frameworks frequently align with the existing international standards. However, others significantly added complexity and breadth to pharmacovigilance requirements, placing avoidable burden on stakeholders without necessarily benefiting patients.
The EFPIA International PV Group has developed a paper presenting the key considerations for the development of effective national PV systems by NRAs as well as options for the pragmatic management of key components of these systems in countries where infrastructure and resources are limited.
This session will provide an overview of the key elements of the paper which aims to deliver a useful reference for interested stakeholders, particularly for NRAs currently developing or refining national PV systems for medicinal products in emerging markets.
Presentation abstract available soon
Inspection and audit have become embedded in the pharmacovigilance quality system as a key tool for successful supervision and oversight of the compliance of our pharmacovigilance systems. The publication of the Good Vigilance Practice Modules III (Pharmacovigilance Inspections) and IV (Pharmacovigilance Audit) in 2012, formally set the standard and expectations of the objectives of pharmacovigilance inspection and audits and there is evidence to demonstrate the positive impact independent inspection and audit can have on PV system compliance and continuous improvement.
In order to ensure continued compliance with a broad range and frequently changing global pharmacovigilance requirements pharmacovigilance systems continuously evolve. Availability of new and improved technologies also challenge our PV systems and inspire PV professionals to assess how traditional PV processes can be transformed to produce more efficient and higher quality outputs. Subsequently, PV systems and the products they support are becoming more complex, larger and diverse. For audit and inspection programmes to continue to add value, it is important that they also adapt to the changing PV landscape in the same way that their counterparts operating the PV system are embracing and implementing change.
The application of risk-based principles within PV audit and inspection programmes is essential to ensure that the available auditor and inspector resource can target the areas of the PV system that have the greatest impact on ensuring patient safety and/or the greatest impact on regulatory compliance. The use of risk-based assessments to identify entities for audit and inspection is well established, however, there is opportunity to continue to develop these assessments, making better use of technology and the increased availability of reliable and consistent compliance data. Further application of risk-based principles into audit planning can be used to drive not just the entities to be audited but, also the scope of each individual audit to further focus resource the areas of greatest risk.
This presentation will assess the current popular approaches to PV audit and inspection, discuss the challenges of operating a successful audit programme and explore how we can shape the future of these programmes.
Sede della Conferenza
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and networking lunch will provide a pleasant moment of refreshment and an opportunity for you to network with your industry peers. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
All our conference facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the conference. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click.
All the necessary information for the Conference is provided. The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance.