Pharmaceutical Regulatory Affairs
Enhance your career in the pharmaceutical industry with LSCOPE’s 3-Month Certification in Pharmaceutical Regulatory Affairs. This comprehensive program is designed for professionals seeking to gain in-depth knowledge and skills necessary to navigate the complex regulatory landscape.
Enhance your career in the pharmaceutical industry with LSCOPE’s 3-Month Certification in Pharmaceutical Regulatory Affairs. This comprehensive program is designed for professionals seeking to gain in-depth knowledge and skills necessary to navigate the complex regulatory landscape.
The program features flexible learning options, allowing you to choose between online and offline modules. This adaptability helps you balance your studies with work commitments effectively. Throughout the course, you will explore essential topics mentioned in curriculum section.
In addition to technical knowledge, this program emphasizes the development of essential soft skills, including communication, teamwork, and problem-solving, which are vital for success in regulatory roles. You will also receive tailored support for job interviews, including mock interviews, resume workshops, and strategies to present yourself effectively in the competitive job market.
Upon completion of this certification, you will be equipped to navigate regulatory requirements for pharmaceuticals in various markets, understand and manage the submission processes for drug approvals, communicate effectively with regulatory bodies and stakeholders, implement risk management strategies, and prepare confidently for job interviews in regulatory affairs.
This program is mostly ideal for professionals into life science stream seeking to transition into regulatory affairs, and individuals aiming to enhance their expertise for career advancement or recent graduates looking to enter the pharmaceutical industry, professionals.
Why LSCOPE?
Globally Entitled Program
Get CPD accredited internationally recognized courses
Industry Experts
Get trained by specialized working professionals with hands on expertise
Globally Entitled Program
Acquire dual certifications in single program
Lifetime Placements
Assured dedicated placement assistance for lifetime validity
On Job Training
Hands on learning with on job training program in masters diploma
Tech Driven Learning
Enhance your upskilling journey with technology enabled learning
Program Benefits
- Cutting-Edge Research: Delve into the forefront of pharmaceutical research with our academic programs, exploring drug discovery, pharmacology, and novel methodologies. Foster your research acumen to contribute to the advancement of pharmaceutical science.
- Interdisciplinary Approach: Our courses encourage interdisciplinary collaboration, bridging the gap between pharmaceutical science and related fields, fostering a holistic understanding of healthcare innovation.
- Teaching Excellence: Learn from seasoned educators and researchers who are passionate about nurturing the next generation of pharmaceutical professionals. Our faculty brings a wealth of knowledge and experience to your learning journey.
- Advanced Industry Insights: Stay ahead in the competitive pharmaceutical industry by gaining knowledge of the latest trends, regulations, and market dynamics. Enhance your proficiency in areas like quality assurance, regulatory affairs, manufacturing, and more.
- Practical Application: Our courses provide practical, hands-on experience through case studies, real-world industry projects, and interactive workshops. Apply your learning immediately in your professional environment.
- Certification and Career Advancement: Acquire certifications that are recognized and valued within the industry. Use your newfound knowledge to open doors to career advancement opportunities.
- Build a robust network of peers, academics, and industry leaders. Engage in collaborative projects, knowledge-sharing, and thought-provoking discussions that will broaden your horizons and inspire new ideas.
- The pharmaceutical industry is a realm of constant innovation, where science meets healthcare, and where research can directly impact human well-being. Our Pharmaceutical Course Training program empowers you to become a driving force in this dynamic field, whether your journey is academic or industry-focused.
- By choosing our courses, you’re investing in a future filled with possibilities. Whether you’re stepping into the world of academia or seeking to sharpen your skills in the pharmaceutical industry, we’re here to guide and support your professional growth. Join us in shaping the future of pharmaceuticals through education, collaboration, and dedication to excellence.
- A hybrid courses provides you with a choice depending on your budget, time and preference. You can attend the course in-person as a classroom training course. Or you can attend the course as a live online training course.
- Using video and microphone technology the classroom training session is delivered over the internet as a live online course. The price reflects your decision with the cost of the live online option being slightly less expensive.
- Our dedicated placement support department which works well to provide best opportunities from the topmost pharmaceutical firms.
- The career services team play a pivotal role, offering resume/CV workshops, mock interviews, and job placement assistance.
Curriculum
This module will cover the following topics:
- The history and evolution of the regulatory profession
- Major Regulations of USA
- EU and its regulatory framework
- Major Rules and Act of India
- Regulatory Network (Global, Regional and National)
- Roles of Regulatory Affairs Professional in Pharmaceutical Industry
This module will cover the following topics:
- Who is Regulatory Authority?
- Role of Regulatory Authority.
- Introduction to some key Regulatory Authorities that currently exist.
This module will cover the following topics:
- Pre-clinical & Clinical Research and its different stages.
- Regulatory Review & Approvals – methodology and what it comprises.
- Commercialisation of Medicines, and various post-approval activities.
- What is post-marketing surveillance, what it involves and why it is necessary.
This module will cover the following topics:
- EU Clinical Trials Directive (Directive 2001/20/EC)
- EU Clinical Trials Regulation (EU No 536/2014)
- Impact of the Regulation
- Post-Brexit Considerations
- Key Components of the CTA Process in the UK
- Key Features of the UK CTA Process
- USA Investigational New Drug (IND) Application
- Key Components of an IND Application
This module will cover the following topics:
- Regulatory Affairs Marketing Authorisation Application
- Centralised Procedure (EU)
- Decentralised Procedure (EU)
- Mutual Recognition Procedure (EU)
- National Procedure (EU/UK)
- Medical device approval.
- New Drug Application (NDA) (US FDA)
- Biologics License Applications (BLA) (US FDA)
- New drug Application in India
This module will cover the following topics:
- Introduction to Medical Devices
- Classification of Medical Devices
- Medical device EU Regulatory Pathways
- Medical device FDA Regulatory Pathways
- Introduction to Eudamed Database
- Introduction to Medical Devices unique device identification (UDI) system
Who Can Enroll?
Candidates who are pursuing their degree into Life science Stream i.e. B. Pharm, BSc, BAMS, MBBS, MSc, M. Pharm, etc or Graduated Fresher and Working Professionals looking to advance their career into Pharmaceutical Industry
Enrolment Process
Registration
Enrolment Form
LMS Access
Once the Enrolment form is Completed our team will review the application and grant the access of LMS portal along with study material and Course content
