Assure Safety Information
How to Assure that all Safety Information is Captured and Collected in the Safety Databases.
pharma
Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass - US edition
09-10 November, 2026
09-10 November, 2026Virtual
This should also be considered in all outsourced activities of a pharmaceutical company that may lead to any capture of safety information related to the products of which the company is the Marketing Authorization Holder (MAH).
09-10 November, 2026, Virtual
Time Zone: Eastern Daylight Time (EDT) - UTC04:00
Key learnings
Definition of Responsibilities
Definition of Responsibilities by all Parties.
Regulatory Authorities
Dealing with the Regulatory Authorities and meeting FDA requirements
Timely Reporting
How to Assure that any Outsourced Activity Allows Collection and Timely Reporting of all Safety-Related Information.
Safety Information
Adequate Collection, Processing and Timely Reporting of Safety Information by all Parties.
Trusted by over 17,000 delegates across leading companies
Overview
It is common in our globalized world that, according to their specific strengths and interests more than one pharmaceutical is involved in the marketing of a pharmaceutical product, even in the same geographical area or country. It is crucial and tightly required by the Regulatory Authorities that the safety information arising at any point is adequately captured, distributed, and adequately and timely reported. The risk-benefit ratio should be maintained at all times and for this reason, agreements between pharmaceutical companies marketing a certain product should include agreements (so-called Safety Data Exchange Agreements, SDAE) to ensure the adequate flow of any arising safety concerns.
This should also be considered in all outsourced activities of a pharmaceutical company that may lead to any capture of safety information related to the products of which the company is the Marketing Authorization Holder (MAH)
#masterclass #glceurope #pharmaonlinetraining #globalleadingconferences #USsafetydataagreements #pharmacovigilance #externalvendors
Meet the expert
Trainer
Joan Francesc Aregall Picamal
PHARMACOVIGILANCE CONSULTANT & DRUG SAFETY & SDEA SPECIALIST
Joan Francesc Aregall is a Pharmacist with and MBA in Pharmaceutical Industry by the Barcelona University. More than 30-year experience in several pharmaceutical companies. First in Regulatory Affairs (for more than 15 years), after sharing Regulatory Affairs and Pharmacovigilance and finally fully devoted to Pharmacovigilance and Safety of Pharmaceutical Products both marketed and under Clinical Development.
In 2016 decided to establish himself as a free-lance and took PV auditing courses at the Research Quality Association (RQA). Since 2012, has been actively participating as a Member of the Spanish Association of Industry Pharmacists as a trainer of different and speaker of PV courses.
In 2016 decided to establish himself as a free-lance and took PV auditing courses at the Research Quality Association (RQA). Since 2012, has been actively participating as a Member of the Spanish Association of Industry Pharmacists as a trainer of different and speaker of PV courses.
Reasons to attend a masterclass
Practical knowledge
Venture into undiscovered territories and gain inspiration through collaboration
Interactivity
Boost your professional skills by directly engaging with domain experts
World-class trainers
Gain value and learn from the best instructors
Networking
Build a top-notch community and advance your career
WHO SHOULD ATTEND
-Pharmacovigilance professionals
-Auditors and PV Auditors
-Medical Affairs Professionals involved in outsourced Medical Activities as Advisory Boards, Congresses, etc
-Marketing Professionals working in outsourcing activities
-Legal Department Professionals
Ticket options for you
Full eventpass
Learn moreLooking for an in-house training?
*minimum of 10 participants
Learn more 14+
Years of experience
600+
Events organized
4,000+
Speakers
25,000+
Attendees
Take the next step
REQUEST AGENDA FORM
Impressions
