A Study on Social Enterprise Policy Landscape in Bangladesh

The purpose of the study is to highlight the policy landscape of the social enterprise which is not spoken in any of the present policies and laws of Bangladesh. This study reviews the existing policies and regulatory affairs related to social enterprise formation and operations in Bangladesh. This study also focuses on the analysis of literature that described the national, regional and international good practices on social enterprise. This study tries to find out the past, present and future insight and findings of social enterprises policy implications in Bangladesh. This study finds the breadth and ranges of the policy approaches that the government has implemented for social enterprise development and policy priority for Bangladesh. Because at present in Bangladesh a social enterprise can establish and operate under different laws as there is no specific policy to register and operate the social enterprise in Bangladesh, so it’s confusing for the social entrepreneur to register under appropriate law that will benefit them in the future. This study is based on the detailed assessment accessible in online literature and current data on social enterprise in Bangladesh, analysis of the existing policies and regulatory affairs on social enterprise in Bangladesh. This study is dependent on the qualitative approach along with the unstructured interviews with the industry experts. This paper presents a solid case study regarding the existing policy and regulatory implications of social enterprise formation and operations in Bangladesh.

A comprehensive synopsis on cognizance of Regulatory Affairs in different sectors of Pharmacy

A pharmaceutical drug regulatory Affairs is mainly involved in registration process parameters of different pharmaceutical products and new drug application. Regulatory affairs (RA) professionals play vital roles in a pharmaceutical field as, it is related to healthcare products. It provides strategic, operational direction and support for working within regulations to expedite the development of pharmaceutical, biological and medical devices. Also, it is principally concern with safety and efficacy, low risk/high benefit and quality assessment of healthcare drug products throughout the world. Regulatory system of each and every country has different regulatory agencies which govern certification and good manufacturing practices. Regulatory Affairs also has a very specific importance within the formulation and marketing of drug product in pharmaceutical industries. Current abstract reports for the first time and emphasizes on studies concerning awareness and knowledge testing in regulatory affair field by the various pharma professionals. This is completely certified online survey of quiz questionnaire based on important concepts in RA and circulated via google form to different social medias to more than 1000 pharma professionals (Academics, Students, Industrials area). The systematic analysis of received responses reveals awareness and knowledge of the participants about RA in selected pharma professionals. It shows that, participants form industrial area having more knowledge than academics and students. This survey comes out with conclusion that, there is more need to raise RA information sources by the inclusion of this subject in syllabus for academics via various courses to fulfill more RA professional demands in future.

ROSTMEMA: A Double-Blind Randomized Placebo-Controlled Trial with the PDE4 Inhibitor Roflumilast in Patients Suffering from Long-term Cognitive Sequela After Stroke

Background : The aim of this study is to examine whether treatment with roflumilast improves cognition in patients suffering from cognitive sequelae after stroke. The results may provide a proof of concept on the potential of roflumilast (or other phosphodiesterase-4 (PDE-4) inhibitors) as pharmacotherapeutic treatment to enhance cognition, and will further increase our knowledge on the role of PDE4 in human cognition in general. Cognitive processes, in particular memory, will be assessed. Methods : 100 female and male patients (41-70 years old) suffering from cognitive complaints 1 year after stroke will be recruited via advertisements via social media and via local caretaking organizations. The first phase of the study will be conducted according to a double-blind, randomized placebo-controlled, between-subjects design. After a baseline measurement, participants will be tested for acute (1 hour after drug intake) and subsequent chronic (1.5 and 3 months after start treatment) treatment effects. In a second phase, the placebo group (50 people) will be given the opportunity to receive roflumilast. This is an open label design. The roflumilast group will be tested for long-term treatment effects at three months after the end of treatment. Discussion : Strengths of the current study are the open-label design as well as the assessment of long-term effects. The findings of the current study will demonstrate if the mechanism of PDE4 inhibition is a relevant target to improve cognitive functions in patients with brain damage after a stroke. If positive effects are found in this patient group, this treatment could also be relevant for other brain disorders (e.g. head trauma, mild cognitive impairment, Fragile X syndrome, schizophrenia) in which enhanced neuronal plasticity is required to improve cognition. Trial registration : The Medical Ethics Committee of Maastricht University Medical Center+ granted ethics approval of the fourth version of the protocol on February 25, 2021. The trial was registered at the European Drug Regulatory Affairs Clinical Trials (EudraCT) register on July 29, 2020, https://www.clinicaltrialsregister.eu/ctr-search/search?query=2020-003768-16 and Clinicaltrials.gov (NCT04854811) at April 21, 2021, https://clinicaltrials.gov/ct2/show/NCT04854811. The Central Committee on Research Involving Human Subjects (CCMO) granted approval on May 4, 2021.