
Step
WHO WE ARE
Step is a medical affairs company committed to excellence in services and innovation. It supports the pharmaceutical industry and other healthcare companies in the pre and post launch of products through the development of medical strategy, medical plan and execution through different types of activities (specialists mapping, advisory boards, training the trainers, education programs medical and other health care professionals, preceptorships, sales force and MSLs training).
We also offer support to the pharmacovigilance area by carrying out Risk management plans, safety periodic reports and labelling and package leaflet review


Medical specialists
Extensive experience working with pharmaceutical industry in medical affairs area, new business development, pharmacovigilance and medical compliance
Customized service

Cristina Stephan, Step’s founder, is a specialist in gynecology / obstetrics and with master’s degree in gynecology. She has over 18 years of experience working in multinational pharmaceutical companies, in local and regional leadership positions, working in different therapeutic areas such as women's health, respiratory, dermatology, central nervous system, pain and OTC medications. Furthermore, she also has experience working with clinical research area, medical compliance, pharmacovigilance, and medical support for new businesses development area.
Step’s team also includes medical consultants, pharmacists, and other health care professionals, with huge experience working in the pharmaceutical industry. They joined the company to contributed to the excellence, commitment and innovation in services provided by Step.

Medical strategy
Development of pre and post launch strategy
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Development of product's medical strategy based on physicians and and patients needs.
Medical plan execution
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Specialists mapping, train the trainers, advisory boards, medical education activities (extended programs, mini-meetings, road shows, preceptorships, symposia), slide decks, messages database, data generation and publication.
Development of medical plan and scientific messages
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Preparation of medical plan and main scientific messages to be worked on, based on local epidemiological data, patient journey, treatment guidelines and analysis experts of opinion.
Scientific and promotional materials review
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Review done according to local legislation, SOPs, company compliance rules, Interfarma, Sindusfarma and ABIMIP rules.

Medical Education
Treinamento de speakers
Development of preceptorships, mini-meetings, round tables and road shows programs
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Preparation of the agenda and main topics
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Speaker’s selection and invitation
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Development of slide deck and supporting materials
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Preparation of the agenda and main topics
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Speaker’s selection and invitation
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Alignment of presentations with speakers
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Slide Review
Symposia
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Preparation of the agenda and main topics
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Speaker’s selection and invitation
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Alignment of presentations with speakers
Slide review
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Facilitating the slide review meeting
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Support on the day of the event

Nurses, pharmacists and caregiver’s education
Pharmacists and nurses
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Development of educational programs and supporting materials as well to enhance disease awareness, available treatments and medication management for nurses, pharmacists and caregivers.
Patients and caregivers
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Development of supporting materials with specific content for this public.

Advisory board
Event planning and execution
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Experts mapping and identifying
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Development of the agenda and main topics
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Content preparation, validation and development of materials for pre-work
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Facilitation of the event
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Final report

Internal teams support
Training plan
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Preparation of training plan and conducting live or virtual training for sales force, medical managers, MSLs
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Development of disease awareness campaign for employees.
Supporting materials
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Development of training manuals, e-learning program, and knowledge tests.

Suporte à farmacovigilância
Development of pharmacovigilance plan*
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Safety Specification (non-clinical and clinical data)
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Routine pharmacovigilance practices
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Action plan on security concerns
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Summary of the pharmacovigilance plan
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Assessment of the need to prepare the risk minimization plan
*According to ICH and Anvisa guidelines
Development of safety periodic reports
Labelling and package leaflet review
