Process Development

"Regulatory Affairs: Basic Protocols" provides a comprehensive guide to the basic concepts and protocols in the pharmaceutical industry. Written in a clear and concise manner, this book covers topics including documentation, chemistry, manufacturing, and controls, as well as the investigation of medicinal product dossier and the development of clinical trial protocols. Throughout the book, readers will learn about the concept of innovator and generic drugs, drug development, and the regulatory guidance and guidelines for filing and approval. This book also explores the preparation of ...

Are you frustrated or disenchanted by the results of your Agile approach? Does Agile sound like a good idea, but you're not sure how to explain it beyond roles, practices, and meetings? Is your team going through the motions, but it's still business as usual? The missing piece is the Agile mindset - the thinking that makes Agile processes work.

Peak-performance psychologist Dr Alia Bojilova draws on her work with the SAS, Olympic athletes, modern leaders and successful entrepreneurs to help you unlock your potential in everyday life. Guiding you through a four-step process - to develop clearer awareness, deeper belonging, broader curiosity and stronger drive - The Resilience Toolkit will help you to embrace the unknown with greater confidence and teach you to recover faster from setbacks.

Train your brain to overcome PTSD, anxiety, negative thoughts, and shyness using this helpful guide. We live in a dog-eats-dog world. Over time, you quickly learn that bad things can happen, and that not everyone has your best intentions in mind, which leads to undue stress, anxiety, and even trauma. This may be a hard pill to swallow, but sometimes...the only person you can truly rely on is yourself. With a strong sense of self-worth and self-efficacy, you can overcome anything!

Heralded as “a book that can strengthen the spirit of its listener and transform or even save lives,” Move Forward Stronger is like a friend when we’re in need, the therapist we’re hesitant to call, and the inner voice we’ve been listening for ... telling us: “You can feel happiness again.” Something happened. The death of someone you love. A suicide, divorce, or loss of a close relationship, job, career, or business. A negative change in your financial picture. A medical diagnosis or tragic accident. A physical or emotional injury. It happened. Now what?

Thanks to technology and marriage equality, more and more people are looking to become parents. Third-party reproduction has become easier, more accessible, and more successful, yet it is a complex process. Regardless of their gender or marital status, people come to the process with questions like, "How are sperm, eggs, embryos, or surrogates screened?", "What are the legal issues surrounding surrogacy?", "How do I find an egg donor?", and "How do I tell my family's story?" Your Future Family is the definitive handbook to answer these important questions.

From Understanding Poverty to Developing Human Capacity details how schools, churches, courts, businesses, and communities can build resources for people in poverty. With nine articles written by Dr. Payne, along with two co-written with her colleague, Philip DeVol, these writings cover the gamut of Dr. Payne's efforts in dealing with poverty-related issues.

When you said your “I Do’s,” you and your spouse had a vision of a future filled with hope and promise. Despite what you face now and where you may be in your relationship, you can regain that vision. Randy and Cathy Boyd have developed the H.E.A.L. process that delves into hope, expectations, acceptance, and listening as factors needed to heal and restore your marriage. In this short book, they’ll guide you to the path you need to take to get you started in the process. They’ve been where you may find yourself now, so they fully understand your challenges.

You don’t have to be brilliant to produce brilliant work. Many of the characters you will meet in this book failed at school, lacked natural talent, were not especially gifted or were repeatedly sacked. But their methods produced brilliant work - and they will work for you, too. Make Brilliant Work is the essential book from Rod Judkins, author of the international best seller The Art of Creative Thinking.

Learn how to grieve in a healthy way, and move on with your grieving process with this guided meditation and relaxation program, from certified hypnotherapist, Joel Thielke. It's as easy as turning on the tracks and falling asleep! The Sleep Learning System is specially designed to work with your subconscious mind during your sleep cycle.

Le livre qui permet d'identifier les situations de triangles dramatiques, et de sortir du rôle de victime, bourreau ou sauveur. Nous expérimentons tous la mise en place de triangles de Karpman dans notre vie et à certains moments, dans nos rapports avec certaines personnes. Se retrouver pris dans un triangle dramatique nous rend mal à l'aise et peut avoir des conséquences très néfastes sur nos relations. Mais avec de bonnes méthodes, il est possible d'en sortir.

Think about the last time you tried to talk with someone about political, social, or environmental issues who didn't already agree with you. How well did it go? These conversations are vital, but too often they get stuck, or we avoid them entirely. We retreat to our camps, frustrated that we can't move our cause forward. What if, in these difficult conversations, we could stay true to ourselves while enriching relationships and creating powerful pathways forward?

Do you want to become a rainmaker, or become a managing director or shareholder? Do your young professionals need a simple, proven, step-by-step marketing process to follow? Want to increase your firm's retention? Get “the profession’s best accounting-marketing book.” In this powerful guidebook, Ross Fishman, called "the nation's leading expert on professional services marketing," details straightforward tactics to accomplish your goals. His renowned Checklists have been used for 25 years by all types of professionals in their successful quests to generate clients. This expanded 50-...

Introducing "The Development-Democratization Conundrum," an all-encompassing, thought-provoking eBook that dives deep into the intricacies and interconnections between economic development and the democratization process! Immerse yourself in a comprehensive exploration of the complexities surrounding these vital concepts in today's world. Journey through the captivating chapters that lay the foundation of this crucial relationship and examine the historical roots of correlation. This eBook reveals the various theories of economic development and takes you through the fascinating stages of ...

In How to Be and Stay Sexy, Allana Pratt explains that it's because women attempt the impossible. They try to be who they are told to be instead of being exactly who they are. Our culture consistently gives women the impression that by behaving a certain way and offering men what society tells us these men want, women can secure a man who provides security, affection, and lasting companionship.

Are you a loving parent seeking to establish a healthy co-parenting relationship with a toxic ex? Would you like to learn how to prevent parental alienation syndrome, and develop a nourishing relationship with your children? Do you want to get your hands on an informative guide that will enable you to protect your children, maintain healthy boundaries with your ex, and ultimately enjoy the process? Great news, this is the only audiobook that will show you how!

Whatever loss you have experienced, this book can help you to make sense of it; guiding you through those difficult and overwhelming emotions, explaining how these fit into the universal psychological process of grieving—and showing you a path to creating a more content life. Psychotherapist Christine Hopfgarten looks in detail at different reasons that we may encounter feelings of loss and grief, including bereavement, relationship break-up, losing a job, infertility, miscarriage and illness, and provides focused help.

If you’re thinking about joining the police service as a police officer, but are confused about the 50 plus different processes, which exist across the United Kingdom, then this audiobook will provide clarity through Brendan’s unique detailed and structured approach. Over the past decade, Brendan O’Brien has coached and supported over 12,000 people to success in the police recruitment process. Now, Brendan will share with you his unique guidance, which will help you to join this success story and secure your position as a police officer.

Jon McGee's Dear Parents is an essential tool you'll need to navigate the complex and often emotional challenge of getting your daughter or son prepared for - and through - college. Organized chronologically, the book takes listeners through the stages of childhood leading up to college, as well as the process of searching for and selecting a college. From the decisions you make during your child's early years to the process of setting up their dorm room, this book provides parents with insights, wisdom, and guidance about college, college preparation, and choosing a college.

You'll find out what it actually means to love yourself and set healthy boundaries—and how on earth you can do it without damaging your relationships and losing what you love.