A Global Pharmacovigilance Network: Opportunities or Threat?
LS Academy is delighted to welcome you to the 2nd International Pharmacovigilance Day 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:
- Pharmacovigilance in first-in-human trials & monitoring guideline
- Safety regulations affecting device-drug and drug-device combination products
- New PRAC strategy for impact assessment of pharmacovigilance: with focus on the strategy to measure impact of pharmacovigilance
- Digital Health: New initiatives
- WEB-RADR & new technologies
- Electronic Product Information & e-label
- Developing effective global PV systems
- Risk Management: How to stay compliant with increasing complexity
A pool of International subject matter experts will share the floor to address the challenges phased by pharmacovigilance experts on a daily basis.
«An Industry and Health Authorities’ perspective at our PV International Day; PV experts presenting hot-topics on safety and pharmacovigilance at an international scale», PV Scientific Committee.
Participants will have the opportunity to take part in up-to-date discussions and to share their own experiences within a greatly qualified international environment. The PV International most 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, Universities
- Open discussions and group working sessions
- Notable networking opportunities
- An easy to access venue and friendly environment
An event is fully designed for professionals involved in safety, pharmacovigilance, 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, Indipendent 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 email@example.com
13 May 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.
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.
14 May 2020
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 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.
The location will be available soon
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.