Regulatory Affairs + GDP 1,5 days

(Certificate provided)

Comprehensive training on relevant regulations and guidelines to fully understand the requirements in submitting new MAs for Human Medicinal Products in Europe. The course will include how to maintain the life cycle management through submitting relevant variations and line extensions, and how to maintain the safety in pre- and post-approval phases, as well as understanding the complexity of working in a matrix organization.

Comprehensive training on all chapters in the EU-GDP legislation and the practical applications of those, leading to understanding how to gain and maintain a Wholesaler license.

GMP Good Manufacturing Practice 1 day

(Certificate provided)

The GMP training course will provide an introduction and basic training with an overview of the pharmaceutical industry cGMP standards. The course will give a solid understanding of how GMP applies to the validation of medical products, focusing on R&D, production, regulations, guidelines, interpretations, requirements and applications.

GDP - Advanced 1 day

(Certificate provided)

Extended course in GDP.

Medical Affairs 2 days

(Certificate provided)

Course in Evidenced Based Marketing within the Pharma-, MedTech- and Biotech industry. Topics includes; Essentials in Health Economy, Swedish Health Authorities and their role(s), Compliance and Ethics, KOL-Development, Market Access and Lifecycle Management. The course also will include – Critical Reviewing of Scientific Articles and Creating a Medical Strategic Plan.

Medical Writing 1 day

(Certificate provided)

This training introduces you to what it takes to create regulatory documents and the skills to succeed in the field. It gives you an overview from a regulatory perspective.

What you’ll learn

• The role and need of a medical writer
• The skills of a succesful medical writer
• Strategies to craft effective messaging
• Strategies to improve document quality

GCP -Good Clinical Practice 1 day

(Certificate provided)

This comprehensive 6-hour course provided in-depth knowledge of Good Clinical Practice (GCP) principles, ensuring thorough understanding and adherence to the ethical and scientific quality standards for designing, conducting, recording, and reporting trials involving human subjects. The course covered fundamental topics like the history and importance of GCP, roles and responsibilities of clinical trial stakeholders, informed consent procedures, trial design, data management, and safety reporting. Attendees were also introduced to regulatory guidelines, quality assurance processes, and the effective utilization of the latest tools and technologies in clinical trials. The course equipped attendees with the skills necessary to maintain the rights, safety, and well-being of trial subjects, ensure data integrity, and navigate the complex regulatory environment of clinical trials, thereby making a significant contribution to the conduct of high-quality, ethical clinical research.

Pharmacovigilance 1 day

(Certificate provided)

This course will provide an introduction to the essential principles and practices of pharmacovigilance, the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. Furthermore, the course will give a comprehensive understanding of drug safety, including regulatory guidelines and industry practices. Topics covered include the history of pharmacovigilance, adverse event reporting, overview of risk management, signal detection and benefit-risk assessment, as well as the latest technologies and tools used in pharmacovigilance. In summary the course will give a solid foundation in the field of pharmacovigilance, ensuring to contribute to the safety of drugs in the market.

Regulatory Affairs - Advanced  1 day

(Certificate provided)

Extended course in Regulatory Affairs.

Advanced Regulatory Affairs (RA) and Pharmaceutical development                                                              

This advanced course is a comprehensive extension of the RA essentials course and is relevant for those who need further insights in Pharmaceutical Development. This course will show how RA applies from early drug discovery and preclinical trials - to -  market authorization (MA) applications, approvals (launch) and  optimizing the important life cycle management. From a regulatory affairs perspective the course will not only indicate strategic preparations before launch but also key strategies during launch and after patent has expired.

The aim of the course is to give the delegates professional reputation building, career and product success enhancement through proper understanding of advanced Regulatory Affairs and related concepts.

The delegates will have a test after the course and then receive a certificate in Advanced Regulatory Affairs.