Regulatory Affairs - Science topic

I hope this email finds you well.

We are excited to extend an invitation for you to join the Organizing Committee for the prestigious Pharma Conference during September 4-5, 2025 in Shanghai, China.

As a respected professional in pharmaceutical field, your input and leadership would help make this event a platform for meaningful advancements in the industry. Pharma Conference will bring together prominent professionals in the field of pharmaceuticals, biotechnology, and healthcare to discuss current challenges and opportunities in drug development, regulatory affairs, and cutting-edge treatments.

As a committee member, you will play a key role in curating the conference agenda and engaging with thought leaders, researchers, and industry experts from around the globe.

In appreciation of your contributions, we are pleased to offer you complimentary registration for the event. Additionally, this role will provide a unique platform to expand your professional network and influence the direction of the pharmaceutical field.

We are confident that your involvement would significantly enhance the quality and impact of the conference.

Thank you for considering this opportunity. We look forward to the possibility of working together to shape the future of the pharmaceutical industry.

With regards Tharun K Conference Manager 2nd Edition of World Congress on Pharmaceutical Research and Biotechnology  Phone: +918019809444

Give in detail with available literature and website links for submissions

When planning a randomized, double-blind trial with multiple arms, there are often challenges for blinding the study treatment/groups due to different formulations/packaging/dosage.

E.g. Study groups

1. treatment A- (spray bottle)

2. treatment B- (drops)

3. treatment C- (drops)

4. Active comparator- (drops)

5. Placebo- (both options possible- spray bottle/drops)

Instead of a double-dummy approach, can we follow group blinding with two or more blinding practices in the same trial?

One blinding group is for treatment A and Placebo as spray bottles.

The blinding second group is for Treatment B and C and Active as drops.

The objective of blinding is to keep the subject and investigator/study team unaware of the treatment assigned, and the same can still be met with the above (with certain limitations of course...)

If you know of any reference trial with such an approach, kindly share.

Thanking you in anticipation.

I'm a medical writer, and recently, I've finished a GCP course. I wanted to know more about regulatory documents such as study protocol, investigator brochure, Informed consent, etc. I wanted to know how they are written and have a look at their formats because I'm interested in this field. Can someone guide me on how to find these documents?

Can anyone explain what is the actual difference between pharma grade material and a cosmetic grade material to be utiliized in a topical product. Since both these materials can be used on skin why there is double standard? It will be great if someone could explain this. 

Thanks in advance 

In Pharmaceutical professional fields such as Regulatory Affairs or Product Development it is of much importance to know the innovator of a product for obvious reasons. But it is not a very simple task using commonly used search engines. I was wondering if any one has a better way to search for them, like a data bank or something.

What are five main issues should be taken into consideration to boost the development of Islamic Banking and Finance today?

Regulatory, product development, shariah compliance, human resource, etc...

ICH Guidelines, 

Discuss the suitability of current regulations for biotechnology medicinal products globally under the following four topics:

(i) Fitness for purpose

(ii) Impact on, and response to innovation

(iii) Impact on the access of medicines to patients

(iv) Any other suitable topic(s)

You should provide, where relevant, examples and identify the regulations

Just curious about why this is. 

Every source/documentation on 3DSlicer warns to use it only for (medical) research because it is not FDA approved. Why would this be, doesn't the FDA deal with approval of these image analysis softwares? (seems unlikely) Or does it lack specific elements required to get approved? Or for other reasons?

If anyone can satisfy my curiosity here, I'm very thankful, you are approved by me ;)

This article discusses the intrusion of federal law into the corporate governance area - an area that was previously the bailiwick of state law. The Sarbanes-Oxley Act of 2002 ("SARBOX") and Dodd-Frank are two prominent examples of this intrusion. Both Acts have as their purpose protection of the public -- the investing public in the case of SARBOX and consumers (as users of products and of credit) in the case of Dodd-Frank. Does creating a public good like "restoring investor confidence" justify federal intrusion into the corporate governance area? It should be kept in mind that SARBOX applies to all corporations listed on American stock exchanges; hence, it has long-arm jurisdiction to reach multinational corporations that are not incorporated in the U.S.

Gwen

I am conducting a study on evaluation of ECD policy implementation and quality service delivery. Therefore, looking for a tool which would help me to quantify quality of the pre-schools environment in Murang'a Kenya

Regulatory regime on biosafety have been developed to keep safe the world from manipulated bioproducts but how much this rule is being followed?

There is a limited regulatory framework for herbal trials in many countries. What is your experience?

When first conceptualized by Stanley R Kay and myself in 1980, we anticipated that the PANSS would be valuable as both a research and clinical tool (this is clearly stated in all versions of the PANSS Manual published initially in 1992 by MultiHealth Systems Inc)--while its rapid acceptance for clinical trials made it familiar to researchers, clinicians wrongly assumed that this was a research tool only.  Stanley Kay died in 1990, leaving me (metaphorically) alone to raise our child; I have of course had help from numerous others but remain perplexed re: how to get clinicians and clinical systems of care to use the PANSS as an outcome measure.

I intend to evaluate the quality of few commercial antibiotic preparations in lab against known bacteria. But to keep myself on right track, I need some workflow document to follow the required steps. We can use the disc diffusion or/and agar dilution method. The aim is to confirm that antibiotic preparation contains sufficient conc. of active antibiotic or not?

Thanks

Asi

 Should we take the legal permission? If yes please guide me.

Does anyone know, if global pharmaceutical/biotech companies/NIH, USA/USFDA, NGOs, etc. will be willing to give/sell us small amounts (mg quantity) of their small molecule compounds (NCEs), where possible toxicity issues hampered their clinical development as cancer therapeutics? We are interested in further exploring Toxicogenomics and mechanism-of-actions of these NCEs in a mouse model of breast cancer? Even NCEs which failed in clinical development against other cancers will be of great research interest to us.

Orphan products could be expensive and generics desired. But many are indicated in severe rare or ultra-rare children conditions making difficult to recruit a homogenous sample, and are not free of side events. Furthermore, the original PK data can be limited. Will comparison in healthy adults be acceptable?

There is no modified release formulation of the study drug in the market. How can I proceed according to EU guidelines?

In recent years, pharma companies had become implicated in global politics as never before. Inequitable drug prices, persisting diverences in national regulatory approaches, and debates over how to define safety and e≈cacy for diverse patient populations around the globe now attract an unprecedented degree of attention. The political, financial, and human health stakes have never been higher for patients, manufacturers, government agencies, or the medical profession.

But now a days the regulations wrapped up in seemingly innocuous pharmaceutical drugs and supposedly standardized regimes for verifying their safety and efficacy. Can this Pharmacopolitics be a suitable tool in regulatory aspects in the clinical trials where the regulatory changes of USA, Europe and Japan will keep updating themselves.

Please share your opinion about the Pharmacopolitics and its implimentation in Clinical studies !