Good Pharmacovigilance Practices (GVP) Professional Certification Program
 |
Price: $695.00 USD |
Download Document your dedication to compliance, safety, and job performance by earning a professional certification. Training Provided By: Biopharma InstituteWebsite: https://www.biopharmainstitute.com Outline/Syllabus: See individual course pages for outline. Description: The Good Pharmacovigilance Practices (GVP) Professional Certification Program includes 4 courses. The first course will help students understand the reasoning behind why Good Pharmacovigilance Practices are needed. Students will receive a basic overview of what pharmacovigilance is and its goals and objectives. We will review ADR, their impacts, their classification by frequency and type, how they are reported, and then we'll look at some examples. At the end of this course student be able to: -Define pharmacovigilance -Identify why pharmacovigilance is needed -Recall the main goals and objectives of pharmacovigilance -Define adverse drug reaction (ADR) -Label ADR with their correct type and frequency -Recall examples of ADR reporting systems The second course will help students understand the fundamental components of the many global pharmacovigilance guidelines, regulations, and reporting programs, with a special emphasis on European Union (or E.U.) Good Pharmacovigilance Practices (or G.V.P.) Guidelines and U.S. Food and Drug Administration (or U.S. F.D.A.) guidance. Pharmacovigilance contributes to the protection of patients and public health in an essential way. For this reason, it is highly important for pharmaceutical manufacturers to follow Good Pharmacovigilance Practices with programs in place that focus on risk assessment and management. The third course in this program will provide a robust introduction to all modules of GVP, enabling you to understand the impact of the GVP modules throughout the pharmacovigilance landscape. This course will also review pharmacovigilance legislation changes over the years. If you are involved in drug safety, pharmacovigilance, regulatory, or quality compliance, this training will help you keep up to date on GVP guidelines. The fourth and final course in the Good Pharmacovigilance Practices (GVP) Professional Certification Program will review recent pharmacovigilance inspections, including the most recent inspections report, remote inspections, and recent inspection findings from for cause and routine inspections over the last few years. This course also will examine several case studies of warning letters issued to real companies that will help you develop a deeper understanding of how Good Pharmacovigilance Practices must be applied in practice. At the end of each case study, students will review actions that can be taken to mitigate the violations. We will also provide a brief overview of the elements of a successful FDA Form 483 response and a highly effective Pharmacovigilance (PV) program. The correct implementation of Good Pharmacovigilance Practices has serious, real-life impacts on patients across the globe and the reputation of drug manufacturers. This program aims to describe these requirements, reasoning, and implications of non-compliance.
|
 | Good Pharmacovigilance Practices (GVP): An Introduction to Pharmacovigilance and Adverse Drug ReactionCourse ID: ELM-920Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | Good Pharmacovigilance Practices (GVP): Legal Framework of the Global Pharmacovigilance ProgramCourse ID: ELM-921Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | Good Pharmacovigilance Practices (GVP): Updates to the European Union GVP GuidelinesCourse ID: ELM-922Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | Good Pharmacovigilance Practices (GVP): Recent Inspections and Warning Letter Case StudiesCourse ID: ELM-923Duration: 30 minutes (0.1 CPD Credits) Price: Included |
Additional Information:
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment for each course within a 12-month period. Certificate of completion is accessible in PDF format immediately after satisfying the requirements.
Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score.
Once all training requirements have been satisfied a professional certification has been achieved and can be verified immediately from our website using a unique ID code located on the certificate. The professional certificate of completion is also instantaneously launched and made available to the student in a PDF format. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode. Furthermore, a digital badge is also issued. The digital badge documents all the courses taken and completed within the program, to further validate the student's achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Badgr, and others, to display accomplishments.
Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity or recertification period for employee compliance training would be determined by those responsible for managing quality within the company.
Benefits of Being Certified from Biopharma Institute: Throughout our training students will be engaging in active learning using interactive eLearning modules validated by 3rd party organizations for relevancy, compliance, and regulatory content. Courses are developed by subject matter experts (SMEs) and instructional design professionals with the goal to promote the students' retaining of key knowledge. The programs further offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 300 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device industries.
Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.
Use our Search Form to Find What You're Looking For:
Benefits of Training with Biopharma Institute
| Immediate access to courses: | Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment. |
| Self-paced, asynchronous eLearning: | 24/7 access to all course materials and assessments for 12 months. |
| Open enrollment: | No prior course prerequisites or work experience required. |
| Expertise: | Courses developed by subject matter experts (SMEs) in the area being taught. |
| Current and validated: | Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited. |
| Optimized for learning: | Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter. |
| Secure and safe access: | Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance. |
| Flexible final assessments: | Multiple-choice questions can be taken repeatedly until a passing score is achieved. |
| Direct access to certificates: | Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode. |
| Verification of training: | Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs. |
| Training manager access: | A proprietary portal offers access to download enrollment reports, training records, account balance, and more. |
| SCORM-compliant courses: | Courses can be delivered directly to most corporate Learning Management Systems (LMS). |
| Purchase orders (POs): | POs are accepted from all companies. Request an invoice when starting the procurement process. |
| Reimbursement: | Some employers may reimburse their employees for training expenses. Check your company's policy. |
| Financial assistance: | Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option. |
| Career advancement: | Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties. |
Have Questions? Contact Us:
Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.
