Pharmacovigilance Global Landscape 2014
Wednesday, May 14, 2014 @ 9:00am EDT
Webinar 1: ADR Management and Reporting to EudraVigilance
Adverse reactions to drugs are unintended or undesired effects of a drug therapy that may significantly influence management decisions. Predictable adverse drug reactions are common. These reactions are dose dependent or related to the pharmacology of the drug and include overdose, side effects, secondary or indirect effects, secondary effects related to underlying disease, and drug-drug interactions. Unpredictable reactions include drug intolerance, idiosyncratic reactions, pseudoallergic reactions, and immunologic reactions.
Adverse drug reactions are a major problem for healthcare services, the pharmaceutical industry and regulators. This has been highlighted recently with some high-profile drug withdrawals and regulatory decisions.
The FDA carefully considers all the available safety information submitted to the agency before a product is approved. However, unexpected and sometimes serious safety problems can emerge once a product goes to market and is used by millions of people.
Adverse Drug Reaction Management and Reporting:
- Timeliness for expedited reporting
- Reporting to EudraVigilance
- Tools and internal industry solutions for being compliant with regulations
- Case studies on ADR reporting
- FDA reporting requirements
Director Drug Safety & Pharmacovigilance / Deputy EU QPPV
Bio: Dr. Marciniak is a highly versatile executive with extensive sales & marketing, scientific and business development experience. He joined PregLem SA in 2010, where he is responsible for supporting a European Centrally Authorised Product registration, management of drug safety with products in early development and establishing a company-wide post-authorisation pharmacovigilance system.
Previously, Dr. Marciniak has proven skills in sales & marketing in numerous therapy areas progressing to business unit manager, after which he decided it was time for a change of scenery and moved into research & development. This is where he started his journey in Pharmacovigilance. Being a self-motivated and talented leader, he was assigned multiple responsibilities interfacing with the Hungarian national regulatory and F. Hoffmann-La Roche Ltd global pharmaceutical projects.
He decided to move into a headquarters and relocated to Switzerland, initially working on vaccine pharmacovigilance prior to joining PregLem SA.
Currently, he is responsible for drug safety & pharmacovigilance, including signal detection, medical writing, supporting regulatory variations and other aspects related to a Centrally Authorised Product and continuing drug development.
Dr. Marciniak was born and raised in Poland and studied and received his medical degree and doctoral degree from the Hungarian Medical University in Szeged.
Wednesday, May 21, 2014 @ 4:30pm EDT
Webinar 2: Pharmacovigilance and Best Practices in Latin America: An Overview on Safety Reporting, ADR management & Scope of ANVISA
The presenter will examine emerging economies, including Latin America: The emerging pharmaceutical market economies, which include Brazil, India, Russia, Argentina, Egypt, Indonesia, Mexico, Pakistan, Poland, Romania, South Africa, Thailand, Turkey, Ukraine, Venezuela, and Vietnam, accrued one fifth of global 2011 pharmaceutical expenditures. The Latin American Study of Adverse Events (IBEAS) is a study on adverse events prevalence in Latin American that aims to analyze the magnitude, significance and impact of adverse events (AE),and identify the main problems associated with patient safety AE.
IBEAS was carried out in a collaborative effort of the governments of Argentina, Colombia, Costa Rica, Mexico and Peru, the Ministry of Health and Social Policy and Equality of Spain, which co-funded the study, the Pan American Health Organization and WHO Patient Safety. In addition to an overview on Brazilian PV Law & submission of periodic reports according Brazilian requirements to National Regulatory Agency, this webinar will discuss:
- Main Sources of Adverse Events
- Expedited Report of ICSRs
- Peculiarities of Aggregate Reports Submission
Merck Sharp & Dohme
Bio: Fernando Pereira has 22 years of pharmacovigilance experience in Brazil, is a former professor of pharmacology and has worked in sentinel hospitals and pharmaceutical companies. He has expertise in pharmacovigilance within a national market, with active participation in pharmaceutical associations, (Interfarma, Sindusfarma). Mr. Pereira is a founding member of the Brazilian Society of Pharmacovigilance, has published papers, spoken at conferences, lectures, and workshops on pharmacovigilance. He has also been actively participating in roundtables and conferences discussing emerging trends and laws concerning the industry.
Thursday, May 29, 2014 @ 2:30pm EDT
Webinar 3: Medical Information Then and Now: Leveraging Technology to Enhance Customer Experience
High quality up to date information about medicines is essential for their safe and effective use in treating patients. Pharmaceutical companies’ medical information departments are a leading source for such information and should be viewed as the most reliable source for medical information on their products.
Historically, medical information departments have used very traditional avenues to receive/respond to customers’ medical inquiries, and medical information has seldom rimed with innovation, partly due to the highly regulated nature of the pharmaceutical industry. In recent years, the use of smart phones and social media platforms for professional purposes has become increasingly popular among health care professionals. The expectation, especially among younger HCPs, is to be able to access drug information in real time. Similarly, as consumers become more and more involved with matters related to their health, increasingly they turn to the internet and to pharma companies for information on their medications, which they use to make informed decisions regarding their therapy alongside their HCPs.
In order to adapt to these changing needs, it has become essential for medical information departments to leverage technology to design new communication channels with their customers. Although this doesn't come without challenges, they are by far outweighed by the opportunities such an initiative can unlock: better connect with customers, increase the outward reach of the department, and expand customer interactions, ultimately to benefit patients.
This session will explore the elements of innovation within Medical Information critical for meeting the evolving needs of our technologically advanced customers. New tools and systems utilized to deliver Medical Information will be presented. Furthermore, we will review innovative electronic methods for capturing customer inquiry in a rapid manner, as well as information on how customer feedback can be collected on an ongoing basis and outcomes used to improve services.
Local Medical Information Officer & Deputy Local Drug Safety Officer
Bio: Dr Noue completed her undergraduate studies at Pierre and Marie Curie university in Paris, France, followed by a masters and doctorate degree in Chemistry at the university of Houston, in Texas.
She started her career on the lab bench working as research scientist in the field of petrochemicals; she later transitioned into pharmaceuticals where she found her niche and passion within medical information and pharmacovigilance; she currently holds this dual role at EMD Serono in Canada, and is the proud recipient of their 2013 circle of excellence award for exemplary individual contributor.
Dr Noue chairs the Pharmacovigilance and medical information network - Canada, a forum where Pharmacovigilance and Medical Information professionals meet to discuss practical solutions with industry peers and regulators to enable ongoing improvements. During her leisure time, when she's not busy with her husband and 3 children, you can find her at the local equestrian club or the local airport as she's an avid horseback rider and pilot.