REPORT ON FACULTY DEVELOPMENT PROGRAMME
Name of the Event: Faculty development programme
Organized By: School of Pharmacy, Noida International University.
DATE OF THE ACTIVITY: 12/08/2024
ABOUT FDP
From 12 August to 17 August 2024, School of Pharmacy, Noida International University will be hosting a 5-days Faculty Development Programme titled “Current Trends and Developments in Pharmaceutical Research” (Hybrid Mode). This program aims to give insights about various novel technologies and strategies implemented in pharmacy domain, which will update faculty members for delivering in-depth knowledge to the
students. This programme gives a platform for several institutions, industries, and researchers
Highlights of the Programme
- Clinical trial methods and regulatory guidelines for novel drug development
- Scientific Discussions regarding latest methodology and regulatory guidelines followed in clinical trial studies.
- Ethical rules and regulations for in-vivo animal studies.
- In-depth knowledge about various regulations and guidelines implemented for animal experimental studies
- Carrer growth and future prospects in Indian Pharmaceutical Industries.
- Imparting various aspects for pre-clinical and clinical research required in drug discovery.
- Requirement of Soft-Skills in Career advancement.
- Overall knowledge enhancement along with dynamic profile development in Academia.
- Good Content and Scientific Writing Skills.
- Sessions for Research and Review Paper writing along with Scientific Blogs and Content.
Patron’s
Chief Patron
Chairman
Noida International University
DEVESH KUMAR SINGH
Chief Patron
Chancellor
VIKRAM SINGH
Noida International University
Patron
Vice-Chancellor
PROF. (DR.) UMA BHARDWAJ
Noida International University
Co-Patron
Dean -R&D
TANVEER AHMAD WANI
Noida International University
Convener
Dean (SOP)
PROF. (DR.) SAMEER KUMAR
Noida International University
Co-Convener
Associate Professor (SOP)
NEHA RANA
Noida International University
Organizing Secretary
Assistant Professor (SOP)
ABHISHEK SHARMA
Noida International University
Resource Person/ Eminent Speakers:
- Mukesh Kumar
Clinical Trial Manager
- NAMRATA GAUTAM
Visiting Faculty, DIPSRU
- Prasoon Kumar Jha
Sr. Manager- L and Ozone Group of Company
- Neha Rana
Associate Professor-SOP, NIU
- Abhishek Sharma
Assistant Professor- SOP, NIU
Organizing Committee
Overall Coordinator
Priti Tiwari Assistant Professor (SOP) Noida International University
IT Support
Raju Singh Assistant Professor (SOP) Noida International University
Scientific content
Anjali Rathee Assistant Professor (SOP) Noida International University
Registration-in charge
Hemant Kumar Assistant Professor (SOP) Noida International University
Certificates and Felicitation
Nidhi Srivastava Mr. Raju Assistant Professor (SOP) Noida International University
Date: August 12, 2024
Time: 11:15 AM – 12:15 PM
Speaker: Mr. Mukesh Kumar, Clinical Trial Manager
Introduction:
The session on Clinical Trial Methodology & Regulatory, delivered by Mr. Mukesh Kumar, provided an extensive overview of the intricate processes and regulatory frameworks that underpin clinical trials. This lecture was crucial for understanding how clinical trials are designed, executed, and monitored to ensure they meet scientific, ethical, and regulatory standards.
Overview of Clinical Trial Methodology:
Mr. Kumar began by outlining the fundamental phases of clinical trials: Phase I, Phase II, Phase III, and Phase IV. He explained that Phase I trials focus on assessing the safety and dosage of a new drug in a small group of healthy volunteers. Phase II trials involve a larger group of participants and aim to evaluate the drug’s efficacy and side effects. Phase III trials are conducted on a larger scale to confirm effectiveness, monitor side effects, and compare the new drug to existing treatments. Phase IV trials, or post-marketing surveillance, gather additional information on the drug's long-term effects and overall effectiveness.
The methodology of clinical trials was discussed in detail, including the design of study protocols, randomization processes, and the importance of blinding to reduce bias. Mr. Kumar emphasized the role of control groups in comparing new treatments against standard or placebo treatments to assess their relative effectiveness.
Regulatory Framework:
The session also covered the regulatory aspects of clinical trials, highlighting the essential role of regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Mr. Kumar discussed the regulatory requirements for trial approval, including the submission of Investigational New Drug (IND) applications and the need for Institutional Review Board (IRB) or Ethics Committee approval.
He elaborated on Good Clinical Practice (GCP) guidelines, which ensure that trials are conducted ethically and that the data obtained are credible and accurate. GCP encompasses aspects such as informed consent, data integrity, and the rights of participants. The importance of adhering to these guidelines was stressed to ensure the validity of trial outcomes and the safety of participants.
Challenges and Considerations:
Mr. Kumar addressed common challenges faced in clinical trials, such as participant recruitment and retention, adherence to protocols, and data management. He discussed strategies to mitigate these challenges, including effective patient engagement practices, comprehensive training for research staff, and robust data management systems.
Ethical Considerations:
Ethical considerations were a significant focus of the session. Mr. Kumar emphasized the necessity of obtaining informed consent from all participants, ensuring they fully understand the risks and benefits of their involvement. The principle of beneficence, which involves maximizing benefits while minimizing harm, was highlighted as a core ethical tenet in clinical research.
Conclusion:
In conclusion, Mr. Kumar’s session provided a comprehensive understanding of both the methodological and regulatory aspects of clinical trials. The detailed exploration of clinical trial phases, regulatory requirements, and ethical considerations equipped participants with the knowledge to navigate the complexities of clinical research effectively. The session underscored the importance of rigorous adherence to guidelines and ethical standards to ensure the success and integrity of clinical trials.
Date:August 13, 2024
Time: 11:15 AM – 12:15 PM
Speaker: Ms. Namrata Gautam, Visiting Faculty, DIPSRU
Introduction:
Ms. Namrata Gautam’s session on the Fundamentals of Intellectual Property Rights (IPR) provided an essential overview of the various forms of intellectual property and the significance of protecting innovations in today’s competitive environment. The session was particularly relevant for researchers, academics, and professionals involved in innovation and technology.
Types of Intellectual Property:
Ms. Gautam began by explaining the different types of intellectual property: patents, trademarks, copyrights, and trade secrets. She detailed how each type serves to protect different aspects of intellectual creations.
Patents: Patents protect new inventions or discoveries and grant exclusive rights to the inventor to produce, use, or sell the invention for a specified period. Ms. Gautam discussed the criteria for patentability, including novelty, non-obviousness, and utility. The patent application process, including the steps for filing and examination, was also covered.
Trademarks: Trademarks safeguard symbols, names, and slogans used to identify goods or services. Ms. Gautam emphasized the importance of trademarks in brand recognition and consumer protection. She explained the process for registering trademarks and the benefits of maintaining trademark protection.
Copyrights: Copyrights protect original works of authorship such as literary, artistic, and musical works. Ms. Gautam highlighted the automatic protection afforded to creators upon the creation of their work and the duration of copyright protection.
Trade Secrets:Trade secrets encompass confidential business information that provides a competitive edge. Examples include formulas, practices, and processes. Ms. Gautam discussed the measures necessary to protect trade secrets, including non-disclosure agreements and internal security protocols.
Importance of Intellectual Property:
Ms. Gautam underscored the crucial role of IPR in fostering innovation and creativity. She illustrated how IP rights incentivize investment in research and development by providing legal protection and potential financial rewards. The protection of IP also plays a vital role in maintaining competitive advantage and market positioning.
Legal Frameworks and Processes:
The session detailed the legal frameworks governing IPR, including international treaties such as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Ms. Gautam discussed the role of national intellectual property offices in administering IP rights and resolving disputes.
Enforcement of IP Rights:
Ms. Gautam emphasized the importance of enforcing intellectual property rights to prevent infringement and protect investments. She covered the legal remedies available for IP infringement, including litigation and alternative dispute resolution methods.
Conclusion:
In summary, Ms. Gautam’s session provided a thorough understanding of the fundamentals of intellectual property rights, highlighting their importance in protecting and leveraging innovations. The detailed explanation of different IP types, legal processes, and enforcement strategies equipped participants with valuable knowledge for navigating the complex world of intellectual property.
DAY 2: SESSION IIND– Good Publishing Practices
Date: August 13, 2024
Time: 2:00 PM – 3:00 PM
Speaker: Dr. Neha Rana, Associate Professor, SOP
Introduction:
Dr. Neha Rana’s session on Good Publishing Practices was designed to guide participants through the essential principles and best practices for publishing academic and research work. The session aimed to enhance participants’ understanding of the publishing process, from manuscript preparation to effective communication of research findings.
Selecting Appropriate Journals:
Dr. Rana began by discussing the importance of selecting the right journal for submitting research work. She emphasized factors to consider, such as the journal’s scope, impact factor, and audience. The session covered strategies for identifying suitable journals, including reviewing their submission guidelines and understanding their peer review processes.
Ensuring Ethical Publishing Practices:
The session addressed the importance of ethical practices in publishing. Dr. Rana covered topics such as plagiarism, authorship, and conflicts of interest
She highlighted the need for proper citation of sources, transparency in reporting research findings, and adherence to ethical guidelines to maintain the integrity of the research process.
Peer Review Process:
Dr. Rana provided an overview of the peer review process, explaining its role in ensuring the quality and credibility of published research. She discussed the different types of peer review, including single-blind, double-blind, and open review. The session included tips for both authors and reviewers on navigating the peer review process effectively.
Manuscript Preparation:
The session provided practical advice on preparing manuscripts for submission. Dr. Rana covered aspects such as structuring the manuscript, writing clear and concise abstracts, and presenting results and discussions effectively. She emphasized the importance of following the journal’s formatting guidelines and ensuring that the manuscript is free of errors.
Communicating Research Findings:
Effective communication of research findings was a key focus of the session. Dr. Rana discussed strategies for presenting results in a clear and compelling manner, including the use of visual aids such as graphs and tables. She also highlighted the importance of writing a well-crafted cover letter and responding to reviewer comments constructively.
Conclusion:
In summary, Dr. Rana’s session provided valuable insights into good publishing practices, covering everything from manuscript preparation to ethical considerations. The practical guidance offered equipped participants with the knowledge and tools needed to navigate the publishing process successfully and contribute to the academic community with high-quality research.
Date: August 14, 2024
Time: 11:15 AM – 12:15 PM
Speaker: Mr. Prasoon Kumar Jha, Sr. Manager-L&D, OZONE Group of Companies
Introduction:
Mr. Prasoon Kumar Jha’s session on the Overview of the Indian Pharma Industry provided an insightful examination of the sector, focusing on career growth and future prospects. The session was designed to offer participants a comprehensive understanding of the industry’s current landscape, emerging trends, and opportunities for professional development.
Current Landscape of the Indian Pharma Industry:
Mr. Jha began with an overview of the Indian pharmaceutical sector, highlighting its growth and significance in the global market. The Indian pharma industry is one of the largest and fastest-growing sectors, with a significant presence in both generic drug production and research and development.
He discussed the industry’s structure, including key players, market segments, and major pharmaceutical hubs. The impact of domestic and international regulations on the industry’s operations was also addressed.
Emerging Trends and Market Dynamics:
The session covered several emerging trends shaping the Indian pharma industry. Mr. Jha discussed advancements in biotechnology, the rise of personalized medicine, and the increasing focus on research and development. The influence of digital technologies, such as artificial intelligence and big data, on drug discovery and development was also explored.
He highlighted the growing importance of regulatory compliance and quality standards in maintaining competitiveness in the global market. The impact of recent policy changes, such as the implementation of the National Medical Devices Policy and the revised Drug Pricing Control Order, was discussed.
Career Growth Opportunities:
Mr. Jha provided insights into career opportunities within the pharma industry. He discussed various career paths, including roles in research and development, manufacturing, regulatory affairs, and sales and marketing. The session emphasized the skills and qualifications required for success in these roles, including technical expertise, analytical skills, and knowledge of regulatory requirements.
He also highlighted the importance of continuous learning and professional development in staying current with industry trends and advancements.
Impact of Technology and Regulatory Changes:
The impact of technological advancements and regulatory changes on career opportunities was a key focus. Mr. Jha discussed how the adoption of new technologies is transforming the industry and creating new career opportunities. He also addressed the need for professionals to adapt to evolving regulatory environments and stay informed about changes in industry standards.
Conclusion:
In conclusion, Mr. Jha’s session provided a comprehensive overview of the Indian pharma industry, offering valuable insights into its current state, emerging trends, and career opportunities. The discussion equipped participants with a deeper understanding of the industry’s dynamics and the skills required to thrive in this evolving sector.
DAY 3: SESSION IIND- CCSEA Regulations for Animal Experimentation in Drug Discovery
Date:August 14, 2024
Time: 2:00 PM – 3:00 PM
Speaker: Mr. Abhishek Sharma, Assistant Professor, SOP
Introduction:
Mr. Abhishek Sharma’s session on CCSEA Regulations for Animal Experimentation in Drug Discovery provided a comprehensive overview of the ethical and regulatory frameworks governing the use of animals in research. The session was essential for understanding the principles and guidelines that ensure humane and ethical practices in drug development.
Overview of CCSEA Regulations:
Mr. Sharma began by introducing the Committee for the Purpose of Control and Supervision of Experiments on Animals (CCSEA) and its role in overseeing animal research in India. He explained the regulatory framework established by CCSEA to ensure that animal experimentation is conducted ethically and in accordance with national and international standards.
Ethical Considerations:
The session emphasized the ethical considerations involved in animal research. Mr. Sharma discussed the principles of the 3Rs: Replacement, Reduction, and Refinement. Replacement involves using alternative methods to avoid animal use when possible. Reduction focuses on minimizing the number of animals used in experiments. Refinement aims to improve the welfare of animals and reduce their suffering.
Mr. Sharma highlighted the importance of obtaining ethical approval for research projects involving animals and the requirement to provide detailed justifications for the use of animals. He discussed the procedures for submitting research proposals to the Institutional Animal Ethics Committee (IAEC) and the criteria for approval.
Compliance with Regulatory Guidelines:
The session covered the specific regulatory guidelines outlined by CCSEA, including the standards for housing, care, and handling of laboratory animals. Mr. Sharma discussed the requirements for maintaining detailed records of animal use, including protocols, health monitoring, and environmental enrichment.
He also addressed the responsibilities of researchers to ensure compliance with CCSEA guidelines and the consequences of non-compliance. The importance of ongoing training and education for research staff was emphasized to maintain high standards of animal care and welfare.
Importance of Humane Practices:
Mr. Sharma stressed the significance of adhering to humane practices in animal research. He discussed the ethical obligation to minimize animal suffering and ensure that research is conducted with the highest level of care and respect for animal welfare.
Conclusion:
In conclusion, Mr. Sharma’s session provided a thorough understanding of the CCSEA regulations and ethical considerations for animal experimentation in drug discovery. The detailed exploration of regulatory guidelines, ethical principles, and compliance measures equipped participants with the knowledge necessary to conduct responsible and humane research in the field of drug development.
Ms. Priti Tiwari, Assistant Professor, SOP
Time: 10:00 AM – 10:15 AM
Ms. Priti Tiwari commenced Day 4 with an inaugural session, setting the stage for the day's activities. Her warm welcome and clear articulation of the day's schedule prepared participants for an engaging and informative series of sessions.
Time: 10:20 AM – 11:20 AM
Session I: Placement Skill Development & Career Enhancement
Speaker: Mr. Devajyoti Datta, Ex Senior Manager, Sanofi India/ Mr. Surojit Ghosh, Ex Senior Manager, Novartis India
Mr. Devajyoti Datta delivered a detailed presentation on placement skills and career enhancement. Drawing from his extensive experience at Sanofi India, he shared valuable strategies for improving job placement success and advancing career development. His insights on resume building, interview techniques, and networking were well-received and provided practical guidance for both faculty and students.
Session : Q&A and Sum Up Session-Mr. Abhishek Sharma, Assistant Professor, SOP
Time 11:30 AM – 12:00 PM
Mr. Abhishek Sharma facilitated the Q&A and summary session, effectively addressing participant queries from the morning's presentations. His ability to distill the key takeaways and clarify complex points ensured that the information from Mr. Datta’s session was well understood and actionable.
Session II: Placement Skill Development & Career Enhancement
Speaker: Mr. Surojit Ghosh, Ex Senior Manager, Novartis India
Time: 2:10 PM – 3:10 PM
Mr. Surojit Ghosh presented a second perspective on placement skill development and career enhancement. His session built upon the morning's topics, offering additional insights into industry-specific skills and career strategies. His practical examples and advice were particularly beneficial for tailoring career strategies to the pharmaceutical industry.
Session : Q&A and Sum Up Session- Mr. Abhishek Sharma, Assistant Professor, SOP
Time: 03:10 PM – 03:30 PM
Mr. Sharma led the final Q&A and summary session for Day 4. He effectively synthesized the afternoon's discussions, addressed remaining questions, and provided a concise recap of key points from both placement skill sessions. His summarization reinforced the day's learning objectives and prepared participants for the following day's activities.
Welcome Note and Inaugural Session- Mr. Hemant Kumar, Assistant Professor, SOP
Date: August 17, 2024
Time: 11:00 AM – 11:15 PM
Mr. Hemant Kumar welcomed participants to Day 5, setting the tone for the focus on research paper writing. His introductory remarks outlined the objectives of the day and underscored the importance of developing strong academic writing skills. His opening effectively engaged participants and prepared them for the detailed sessions to follow.
Speaker: Dr. Yogesh Murti, Associate Professor, GLA University
Time: 11:15 AM – 12:15 PM
Dr. Yogesh Murti provided a comprehensive session on academic writing skills. He covered essential aspects of research paper writing, including structure, clarity, and common pitfalls. His practical advice and techniques were invaluable for participants aiming to enhance their academic writing capabilities. The session was interactive, with participants benefiting from Dr. Murti’s expert guidance.
Q&A and Session - Mrs. Anjali , Assistant Professor, SOP
Time: 12:15 PM – 12:30 PM ;
Mrs. Anjali moderated the Q&A and summary session, addressing participant questions regarding Dr. Murti’s presentation. He provided a clear summary of the session’s key points and ensured that all participant queries were resolved. Her ability to succinctly capture the essence of the discussion enhanced the overall learning experience.
Valedictory Session
Dr. Neha's Opening Remarks for the Valedictory Session
Good afternoon everyone,
It gives me immense pleasure to welcome you all to the valedictory session of our Faculty Development Program on “Current Trends and Developments in Pharmaceutical Research”. As we come to the conclusion of this enriching journey, I want to take a moment to reflect on the insights we've gained and the relationships we've built over the past 5 days.
This program was designed with the aim of The primary aim of this Faculty Development Program is to provide an in-depth understanding of the latest trends, innovations, and advancements in the field of pharmaceutical research., and I believe that together, we have achieved something truly remarkable. The level of engagement, the quality of discussions, and the passion that each of you has brought to the table are truly commendable.
Before we proceed with the final part of our program, I would like to express my sincere thanks to speakers, organizers, and participants. Your contributions have been invaluable in making this program a success.
